Franklin Lakes, NJ, United States
Becton Dickinson & Company recalls
96 recalls recorded since 2018, most recently on 13 August 2026. 36 are listed as ongoing. Status and classification are as published by the FDA.
Recalls96
Ongoing (FDA)36
Terminated or completed60
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 13 August 2026
- Reason
- Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0139-2027, Z-0140-2027
- BD Phoenix Panel NMIC-312. Catalog Number: 449082.
- BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Ongoing Class II Medical devices
- Recall started
- 11 August 2026
- Reason
- Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
- Distribution
- Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Grand Cayman.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3250-2026
- ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of
Ongoing Class I Medical devices
- Recall started
- 27 April 2026
- Reason
- This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2251-2026, Z-2250-2026, Z-2257-2026, Z-2255-2026, Z-2249-2026, Z-2253-2026, Z-2254-2026, Z-2248-2026, Z-2252-2026, Z-2256-2026
- BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
- BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
- BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.
- BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 40
- BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.
- BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.
- BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.
- BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 April 2026
- Reason
- Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
- Distribution
- Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2203-2026, Z-2204-2026, Z-2202-2026
- Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
- Swan-Ganz Pacing Catheter, Models: D200F7;
- Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Ongoing Class II Medical devices
- Recall started
- 7 April 2026
- Reason
- BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1982-2026, Z-1983-2026
- BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
- BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Ongoing Class II Medical devices
- Recall started
- 27 January 2026
- Reason
- During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- Distribution
- US Nationwide distribution in the states of California and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1496-2026
- 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Ongoing Class II Medical devices
- Recall started
- 23 October 2025
- Reason
- The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
- Distribution
- Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0484-2026
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Ongoing Class II Medical devices
- Recall started
- 14 October 2025
- Reason
- BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0504-2026
- BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Ongoing Class II Medical devices
- Recall started
- 23 September 2025
- Reason
- Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Distribution
- Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0235-2026, Z-0237-2026, Z-0240-2026, Z-0236-2026, Z-0238-2026, Z-0239-2026
- BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC
- BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
- BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
- BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240
- BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
- BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Ongoing Class II Medical devices
- Recall started
- 23 June 2025
- Reason
- Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2162-2025
- BD COR System Software. Model Number: 444829.
Ongoing Class II Medical devices
- Recall started
- 20 May 2025
- Reason
- BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE, BN, BR, CA, CN, CR, DO, GT, HK, HT, ID, IN, JP, KH, KR, MO, MX, MY, NP, NZ, PE, PH, PK, SG, SV, TH, TW, VN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2023-2025
- BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Ongoing Class II Medical devices
- Recall started
- 12 February 2025
- Reason
- One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
- Distribution
- Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1296-2025
- BD BBL TB Stain Kit K, Catalog (REF): 212522
Ongoing Class II Medical devices
- Recall started
- 19 December 2024
- Reason
- Potential for signal drift in specific lots of BD PCR Cartridges.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, T
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1004-2025
- BD PCR Cartridges used with MAX System. Model Number: 437519
Ongoing Class II Medical devices
- Recall started
- 6 November 2024
- Reason
- BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0621-2025
- BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly gro
Ongoing Class II Medical devices
- Recall started
- 31 October 2024
- Reason
- BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0589-2025, Z-0591-2025, Z-0590-2025, Z-0593-2025, Z-0584-2025, Z-0586-2025, Z-0596-2025, Z-0588-2025, Z-0585-2025, Z-0587-2025, Z-0594-2025, Z-0595-2025 and 1 more
- BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
- BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
- BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
- BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
- BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
- BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
- BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
- BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 September 2024
- Reason
- Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy
- Distribution
- Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada, Mexico, China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0026-2025
- BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations wher
Ongoing Class II Medical devices
- Recall started
- 1 August 2024
- Reason
- Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3246-2024, Z-3247-2024
- BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and f
- BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative a
Ongoing Class II Medical devices
- Recall started
- 18 July 2024
- Reason
- May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Per
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2686-2024
- BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
- Distribution
- US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2585-2024
- BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Ongoing Class II Medical devices
- Recall started
- 7 May 2024
- Reason
- Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
- Distribution
- Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2023-2024
- BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Ongoing Class II Medical devices
- Recall started
- 29 February 2024
- Reason
- Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected . Esculin is expected to trigger this fluorescence and test cancellation.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1399-2024, Z-1398-2024
- BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use
- BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use
Ongoing Class II Medical devices
- Recall started
- 8 January 2024
- Reason
- There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1037-2024, Z-1015-2024, Z-1038-2024, Z-1021-2024, Z-1011-2024, Z-1034-2024, Z-1017-2024, Z-1020-2024, Z-1040-2024, Z-1033-2024, Z-1022-2024, Z-1018-2024 and 18 more
- BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
- BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
- BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
- BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
- Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
- BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
- BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
- BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
- and 22 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 November 2023
- Reason
- An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX,UT, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0736-2024
- PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Ongoing Class II Medical devices
- Recall started
- 11 October 2023
- Reason
- Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the cou
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0350-2024, Z-0351-2024, Z-0349-2024
- BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE
- BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-POR
- BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (
Ongoing Class II Medical devices
- Recall started
- 12 September 2023
- Reason
- Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0110-2024
- BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Ongoing Class II Medical devices
- Recall started
- 8 June 2023
- Reason
- There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
- Distribution
- US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2099-2023
- BD Synapsys Informatics Solution, Catalog Number 444150
Ongoing Class II Medical devices
- Recall started
- 1 May 2023
- Reason
- IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1682-2023
- BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influen
Ongoing Class II Medical devices
- Recall started
- 22 March 2023
- Reason
- Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+" solution is indicated for use in the clinical laboratory.
- Distribution
- Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1415-2023
- BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-d
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1240-2023, Z-1242-2023, Z-1237-2023, Z-1244-2023, Z-1239-2023, Z-1243-2023, Z-1241-2023, Z-1238-2023
- BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
- BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
- BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
- BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
- BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
- BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
- BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
- BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
Ongoing Class II Medical devices
- Recall started
- 21 November 2022
- Reason
- Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0473-2023
- BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Ongoing Class II Medical devices
- Recall started
- 13 October 2022
- Reason
- Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0232-2023
- BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agen
Ongoing Class II Medical devices
- Recall started
- 15 September 2022
- Reason
- The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
- Distribution
- Distribution US nationwide, Canada, New Zealand, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0095-2023
- BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Ongoing Class II Medical devices
- Recall started
- 18 July 2022
- Reason
- Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
- Distribution
- US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1555-2022
- BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapo
Ongoing Class II Medical devices
- Recall started
- 9 May 2022
- Reason
- May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lank
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1433-2022, Z-1432-2022, Z-1440-2022, Z-1438-2022, Z-1434-2022, Z-1441-2022, Z-1437-2022, Z-1439-2022, Z-1435-2022, Z-1436-2022, Z-1431-2022
- BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
- BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
- Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
- BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
- BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
- Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
- BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
- BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 9 March 2022
- Terminated
- 19 January 2024
- Reason
- When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
- Distribution
- Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1018-2022
- BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Ongoing Class III Medical devices
- Recall started
- 6 January 2022
- Reason
- May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
- Distribution
- US Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0665-2022
- BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacu
Ongoing Class II Medical devices
- Recall started
- 5 January 2022
- Reason
- May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Phili
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0630-2022
- BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Terminated Class II Medical devices
- Recall started
- 27 September 2021
- Terminated
- 4 May 2023
- Reason
- Holes in product packaging impacts package integrity and may compromise sterility.
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0179-2022
- BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Terminated Class II Medical devices
- Recall started
- 24 March 2021
- Terminated
- 2 August 2022
- Reason
- BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1416-2021
- BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
Terminated Class II Medical devices
- Recall started
- 17 March 2021
- Terminated
- 5 August 2022
- Reason
- Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1377-2021, Z-1378-2021
- BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
- BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
Terminated Class II Medical devices
- Recall started
- 7 January 2021
- Terminated
- 3 December 2021
- Reason
- Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0954-2021
- BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV
Terminated Class II Medical devices
- Recall started
- 23 December 2020
- Terminated
- 21 November 2022
- Reason
- The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
- Distribution
- Distribution US nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1109-2021
- BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Terminated Class II Medical devices
- Recall started
- 9 December 2020
- Terminated
- 10 August 2022
- Reason
- BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications
- Distribution
- Alabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia. Foreign: Australia, Canada, Belgium and Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0924-2021, Z-0923-2021
- BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
- BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
Terminated Class II Medical devices
- Recall started
- 8 December 2020
- Terminated
- 3 October 2023
- Reason
- BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0761-2021, Z-0762-2021, Z-0763-2021, Z-0765-2021, Z-0759-2021, Z-0764-2021, Z-0760-2021, Z-0766-2021
- BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-po
- BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram
- BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-po
- BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-p
- BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram
- BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram
- BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram
- BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-po
Terminated Class II Medical devices
- Recall started
- 18 November 2020
- Terminated
- 15 February 2024
- Reason
- BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0588-2021
- BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 8 September 2023
- Reason
- Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0508-2021
- BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Terminated Class II Medical devices
- Recall started
- 14 September 2020
- Terminated
- 27 September 2021
- Reason
- Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
- Distribution
- US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0125-2021
- BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample
Terminated Class II Medical devices
- Recall started
- 14 September 2020
- Terminated
- 9 November 2021
- Reason
- Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
- Distribution
- Foreign: Italy, Spain, and UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0295-2021, Z-0294-2021
- Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
- Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
Terminated Class II Medical devices
- Recall started
- 28 July 2020
- Terminated
- 23 April 2021
- Reason
- Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2889-2020
- BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Terminated Class II Medical devices
- Recall started
- 20 July 2020
- Terminated
- 13 July 2021
- Reason
- BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Ph
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2754-2020
- BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasa
Terminated Class II Medical devices
- Recall started
- 19 June 2020
- Terminated
- 29 July 2022
- Reason
- Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2662-2020, Z-2667-2020, Z-2670-2020, Z-2668-2020, Z-2666-2020, Z-2661-2020, Z-2660-2020, Z-2669-2020, Z-2665-2020, Z-2664-2020, Z-2663-2020, Z-2671-2020
- PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199)
- SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
- PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075
- SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 0080
- SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031
- PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI
- PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
- SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 0080174
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 16 April 2020
- Terminated
- 1 September 2021
- Reason
- This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2065-2020
- BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Terminated Class II Medical devices
- Recall started
- 14 April 2020
- Terminated
- 10 February 2022
- Reason
- May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2046-2020, Z-2047-2020, Z-2048-2020
- BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the
- BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the d
- BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or speci
Terminated Class II Medical devices
- Recall started
- 26 March 2020
- Terminated
- 21 August 2020
- Reason
- The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
- Distribution
- Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1795-2020
- CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
Terminated Class II Medical devices
- Recall started
- 17 March 2020
- Terminated
- 21 October 2020
- Reason
- Iincorrectly packaged without the required lidocaine as labeled
- Distribution
- AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1946-2020
- PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Terminated Class II Medical devices
- Recall started
- 26 February 2020
- Terminated
- 22 September 2020
- Reason
- The kits contain surgical gowns which were subject to a recall by the supplier.
- Distribution
- The products were distributed to the following US states: IN, MO, OH, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2078-2020, Z-2082-2020, Z-2076-2020, Z-2077-2020, Z-2079-2020, Z-2081-2020, Z-2075-2020, Z-2080-2020
- BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
- BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
- BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
- BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
- BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
- BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
- BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
- BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
Terminated Class II Medical devices
- Recall started
- 4 November 2019
- Terminated
- 19 November 2020
- Reason
- The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only
- Distribution
- Nationwide Foreign: UK, Belgium, Australia, Japan, Canada, Taiwan, Colombia, Chile, Philippines, Thailand, Brazil, Hong Kong, Chile, Argentina, Mexico, India, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0518-2020
- Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasou
Terminated Class II Medical devices
- Recall started
- 14 October 2019
- Terminated
- 16 October 2020
- Reason
- Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
- Distribution
- Distribution US Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0500-2020, Z-0499-2020
- BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
- BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Terminated Class II Medical devices
- Recall started
- 16 September 2019
- Terminated
- 29 June 2020
- Reason
- A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
- Distribution
- Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0285-2020
- 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media,
Terminated Class II Medical devices
- Recall started
- 1 August 2019
- Terminated
- 6 May 2020
- Reason
- Product Pouches may not be sealed properly and compromise the sterility of the device
- Distribution
- CA, IL Foreign: Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2411-2019
- 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Terminated Class II Medical devices
- Recall started
- 31 July 2019
- Terminated
- 27 July 2020
- Reason
- Separation of front and rear barrels upon activation of the safety feature that retracts the needle
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0193-2020
- BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, con
Terminated Class II Medical devices
- Recall started
- 26 July 2019
- Terminated
- 6 December 2019
- Reason
- An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
- Distribution
- Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2439-2019, Z-2438-2019
- BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
- BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Terminated Class II Medical devices
- Recall started
- 17 July 2019
- Terminated
- 13 May 2020
- Reason
- The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Distribution
- AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2337-2019, Z-2332-2019, Z-2323-2019, Z-2338-2019, Z-2321-2019, Z-2339-2019, Z-2327-2019, Z-2324-2019, Z-2328-2019, Z-2336-2019, Z-2326-2019, Z-2333-2019 and 7 more
- Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
- Kit BD Max StaphSR; Catalog # 443418
- Kit BD Max ExK DNA 1 USA; Catalog # 442817
- Kit EXT Enteric Bacterial Panel; Catalog # 443812
- Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
- Kit BD Max Enteric Viral Panel EU Catalog # 443985
- Kit BD Max ExK TNA 2; Catalog # 442825
- Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
- and 11 more product lines
Terminated Class II Medical devices
- Recall started
- 12 June 2019
- Terminated
- 29 June 2020
- Reason
- False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- Distribution
- Worldwide Distribution, including US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2300-2019, Z-2301-2019, Z-2305-2019, Z-2296-2019, Z-2308-2019, Z-2297-2019, Z-2307-2019, Z-2303-2019, Z-2309-2019, Z-2299-2019, Z-2310-2019, Z-2306-2019 and 3 more
- BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
- BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
- BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
- BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
- and 7 more product lines
Terminated Class II Medical devices
- Recall started
- 3 June 2019
- Terminated
- 8 December 2020
- Reason
- The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.
- Distribution
- The products were distributed to the following US states: AL, CA, CT, FL, GA, IL, KY, MD, MN, MO, OH, PA, TN, TX, VA, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1967-2019
- BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport
Terminated Class II Medical devices
- Recall started
- 30 May 2019
- Terminated
- 5 May 2020
- Reason
- Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)
- Distribution
- US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2279-2019
- BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Terminated Class II Medical devices
- Recall started
- 13 May 2019
- Terminated
- 6 August 2020
- Reason
- Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- Distribution
- Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0059-2020, Z-0058-2020, Z-0056-2020, Z-0060-2020, Z-0054-2020, Z-0055-2020, Z-0061-2020, Z-0057-2020
- BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
- BD Microtainer SST- Amber Part/Catalog Number: 365978
- BD Microtainer SST Part/Catalog No.365967
- BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
- BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
- BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
- BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
- BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
Terminated Class I Medical devices
- Recall started
- 6 May 2019
- Terminated
- 19 July 2021
- Reason
- An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
- Distribution
- Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1770-2019
- Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-
Terminated Class II Medical devices
- Recall started
- 2 May 2019
- Terminated
- 30 November 2021
- Reason
- After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
- Distribution
- Nationwide Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0049-2020
- CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Terminated Class II Medical devices
- Recall started
- 10 April 2019
- Terminated
- 22 December 2020
- Reason
- BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Argentina Australia Austria Belgium Brazil Canada Chile China Colombia Croatia Cyprus Czech Republic Denmark Finland France Germany Hungary India Italy Japan Jordan Kuwait Lebanon Mexico Morocco Netherlands Norway O
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0284-2020
- MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266
Terminated Class II Medical devices
- Recall started
- 3 April 2019
- Terminated
- 4 May 2020
- Reason
- Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
- Distribution
- Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1314-2019, Z-1313-2019
- BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
- BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Terminated Class II Medical devices
- Recall started
- 7 March 2019
- Terminated
- 12 May 2020
- Reason
- The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
- Distribution
- US distribution to the states of FL and NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1122-2019
- BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Terminated Class II Medical devices
- Recall started
- 7 March 2019
- Terminated
- 11 February 2022
- Reason
- BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
- Distribution
- Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0252-2020
- BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Terminated Class II Medical devices
- Recall started
- 5 March 2019
- Terminated
- 15 July 2020
- Reason
- The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
- Distribution
- Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1121-2019, Z-1120-2019
- Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
- Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Terminated Class II Medical devices
- Recall started
- 1 March 2019
- Terminated
- 21 May 2020
- Reason
- Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
- Distribution
- US distribution to one distributor in VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1710-2019
- BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Terminated Class I Medical devices
- Recall started
- 28 February 2019
- Terminated
- 30 July 2020
- Reason
- Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
- Distribution
- US Nationwide Distribution in the states of AR, NH, NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1210-2019
- SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Terminated Class II Medical devices
- Recall started
- 21 February 2019
- Terminated
- 17 April 2020
- Reason
- BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
- Distribution
- Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1051-2019
- BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activit
Terminated Class II Medical devices
- Recall started
- 1 February 2019
- Terminated
- 11 June 2020
- Reason
- The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- Distribution
- The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2007-2019, Z-2008-2019
- 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
- 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Terminated Class II Medical devices
- Recall started
- 14 January 2019
- Terminated
- 3 April 2020
- Reason
- False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.
- Distribution
- Worldwide Distribution: US (nationwide) to states of:CA, GA, HI, ID, MI, MN, MT, NJ, NM, OH, OR, PA, SC, TX, VA, VT, WA ; and to countries of: Australia, New Zealand, Canada, Europe, and Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0981-2019
- BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for
Terminated Class II Medical devices
- Recall started
- 20 December 2018
- Terminated
- 10 April 2020
- Reason
- Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries:
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0934-2019, Z-0935-2019, Z-0933-2019
- Phoenix AST Indicator, Catalog Number 246004
- Phoenix AP AST Indicator Bag, Catalog Number 246006
- Phoenix AST-s Indicator, Catalog Number 246009
Terminated Class II Medical devices
- Recall started
- 22 October 2018
- Terminated
- 3 April 2020
- Reason
- a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0528-2019
- BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Terminated Class II Medical devices
- Recall started
- 26 September 2018
- Terminated
- 13 April 2020
- Reason
- The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Guam. The products were distributed to the following foreign countries: Canada, United
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0387-2019, Z-0386-2019
- PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1
- PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. C
Terminated Class II Medical devices
- Recall started
- 24 September 2018
- Terminated
- 10 April 2020
- Reason
- A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
- Distribution
- Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0313-2019, Z-0312-2019
- BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and puri
- BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable
Terminated Class III Medical devices
- Recall started
- 21 September 2018
- Terminated
- 25 April 2019
- Reason
- The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.
- Distribution
- Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0081-2019
- BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of
Terminated Class II Medical devices
- Recall started
- 30 August 2018
- Terminated
- 21 October 2020
- Reason
- BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.
- Distribution
- Illinois
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0491-2019, Z-0494-2019, Z-0493-2019, Z-0492-2019
- BD Vacutainer Urine Collection Cups, Cat. No. 364941
- KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
- KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
- BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Terminated Class II Medical devices
- Recall started
- 23 August 2018
- Terminated
- 28 February 2020
- Reason
- One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
- Distribution
- Worldwide Distribution -US Nationwide in the states of: CA, CO, FL, GA, IL, LA, MI, ND, NE, NY, OH, PA, RI, SC, VA, WA and WV. The products were distributed to the following foreign countries: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0384-2019
- BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or cathe
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 9 July 2019
- Reason
- A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
- Distribution
- US Distribution in states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, ID, IN, KS, KY, MA, MI, MS, MT, NC, JH, NY, OK, OR, PA, SC, TN, TX, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2869-2018
- BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
Terminated Class II Medical devices
- Recall started
- 11 April 2018
- Terminated
- 10 May 2019
- Reason
- Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
- Distribution
- US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2260-2018, Z-2258-2018, Z-2259-2018
- The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate add
- The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate add
- The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate add
Terminated Class I Medical devices
- Recall started
- 22 March 2018
- Terminated
- 25 July 2022
- Reason
- BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
- Distribution
- Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1142-2018, Z-1141-2018, Z-1140-2018, Z-1139-2018
- BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903
- BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)
- BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
- BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414)
Terminated Class II Medical devices
- Recall started
- 20 March 2018
- Terminated
- 20 April 2020
- Reason
- Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
- Distribution
- US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1533-2018, Z-1532-2018, Z-1531-2018
- BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
- BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
- BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Terminated Class III Medical devices
- Recall started
- 2 March 2018
- Terminated
- 2 July 2018
- Reason
- The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
- Distribution
- Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1544-2018, Z-1545-2018
- BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
- BD MAX DNA MMK Lab Use, catalog no. 442828
Terminated Class II Medical devices
- Recall started
- 13 February 2018
- Terminated
- 9 March 2020
- Reason
- Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
- Distribution
- US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2056-2018, Z-2055-2018
- BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
- BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Terminated Class II Medical devices
- Recall started
- 3 October 2017
- Terminated
- 9 October 2018
- Reason
- HighPuragar was mislabeled and inadvertently sold as Noble Agar.
- Distribution
- USA (nationwide) Distribution to the states of and including Puerto Rico : AL, AZ, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA,TN, TX, UT, VA, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0935-2018
- Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when inc
Terminated Class II Medical devices
- Recall started
- 18 September 2017
- Terminated
- 4 February 2019
- Reason
- Increased amount of residual blood present on the top of stopper well after venipuncture
- Distribution
- USA (nationwide)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1180-2018
- BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous bloo
Terminated Class II Medical devices
- Recall started
- 29 August 2017
- Terminated
- 16 May 2019
- Reason
- A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0968-2018
- BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Terminated Class II Medical devices
- Recall started
- 18 July 2017
- Terminated
- 9 July 2018
- Reason
- BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
- Distribution
- US and OUS.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0392-2018, Z-0393-2018, Z-0394-2018
- BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
- BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
- BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.