Allentown, PA, United States
B. Braun Medical, Inc. recalls
62 recalls recorded since 2018, most recently on 19 August 2026. 36 are listed as ongoing. Status and classification are as published by the FDA.
Recalls62
Ongoing (FDA)36
Terminated or completed26
Class I (FDA)14
Ongoing Class I Drugs
- Recall started
- 19 August 2026
- Reason
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0869-2026
- 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Ongoing Class I Drugs
- Recall started
- 12 August 2026
- Reason
- Presence of Particulate matter.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0832-2026
- Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
Ongoing Class II Medical devices
- Recall started
- 4 August 2026
- Reason
- Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3089-2026
- Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Ongoing Class I Medical devices
- Recall started
- 6 May 2026
- Reason
- These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2277-2026, Z-2276-2026, Z-2278-2026
- Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupi
- Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (3
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGI
Ongoing Class I Drugs
- Recall started
- 28 April 2026
- Reason
- Presence of Particulate Matter.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0540-2026
- Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Ongoing Class II Drugs
- Recall started
- 2 April 2026
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0496-2026, D-0498-2026, D-0497-2026, D-0495-2026
- DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
- LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Ongoing Class I Medical devices
- Recall started
- 19 March 2026
- Reason
- Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1801-2026, Z-1798-2026, Z-1800-2026, Z-1803-2026, Z-1802-2026, Z-1799-2026
- B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
- B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
- B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
- B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Ongoing Class II Medical devices
- Recall started
- 2 February 2026
- Reason
- The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1483-2026, Z-1482-2026, Z-1481-2026
- Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to ex
- Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used tempo
- Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used
Ongoing Class II Medical devices
- Recall started
- 29 January 2026
- Reason
- B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
- Distribution
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2266-2026, Z-2263-2026, Z-2269-2026, Z-2265-2026, Z-2264-2026, Z-2267-2026, Z-2268-2026, Z-2270-2026
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No
- Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
- Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No
Ongoing Class II Medical devices
- Recall started
- 29 October 2025
- Reason
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Distribution
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0617-2026, Z-0656-2026, Z-0616-2026, Z-0712-2026, Z-0647-2026, Z-0607-2026, Z-0640-2026, Z-0639-2026, Z-0679-2026, Z-0705-2026, Z-0675-2026, Z-0651-2026 and 104 more
- Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with cor
- Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with
- SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with cor
- Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresp
- Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding c
- Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with correspondi
- and 108 more product lines
Ongoing Class I Medical devices
- Recall started
- 30 September 2025
- Reason
- The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
- Distribution
- Domestic: US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0070-2026
- Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Ongoing Class II Medical devices
- Recall started
- 18 September 2025
- Reason
- Potential for the lid of the catheter connector to be in the incorrect position.
- Distribution
- Nationwide distribution to AK, AL, AR, 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 numbers
- Z-0116-2026, Z-0125-2026, Z-0123-2026, Z-0115-2026, Z-0122-2026, Z-0114-2026, Z-0126-2026, Z-0120-2026, Z-0124-2026, Z-0119-2026, Z-0118-2026, Z-0117-2026 and 1 more
- PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Descr
- Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Pr
- Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product
- PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Desc
- ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERI
- PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE
- Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL.
- PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description
- and 5 more product lines
Ongoing Class II Drugs
- Recall started
- 26 August 2025
- Reason
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0653-2025, D-0652-2025
- 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
- STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Ongoing Class I Drugs
- Recall started
- 18 August 2025
- Reason
- Presence of Particulate Matter.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0628-2025, D-0627-2025
- 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
- Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Ongoing Class II Drugs
- Recall started
- 4 August 2025
- Reason
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0586-2025, D-0585-2025
- 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
- Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Ongoing Class I Medical devices
- Recall started
- 9 July 2025
- Reason
- Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
- Distribution
- US distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY. International distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2176-2025
- Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Ongoing Class II Drugs
- Recall started
- 16 June 2025
- Reason
- Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0491-2025
- 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Ongoing Class II Drugs
- Recall started
- 31 March 2025
- Reason
- Presence of Particulate Matter
- Distribution
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0353-2025
- 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Ongoing Class II Medical devices
- Recall started
- 17 February 2025
- Reason
- Increased risk for valve housing detachment causing leakage.
- Distribution
- Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1397-2025
- Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Ongoing Class II Medical devices
- Recall started
- 4 December 2024
- Reason
- Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
- Distribution
- US Nationwide distribution in the states of MO, OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1021-2025
- Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Ongoing Class II Medical devices
- Recall started
- 15 August 2024
- Reason
- Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3173-2024, Z-3175-2024, Z-3174-2024, Z-3178-2024, Z-3177-2024, Z-3176-2024, Z-3179-2024
- SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
- STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
- STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
- STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
- STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
- STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
- STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- Reason
- Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3144-2024
- AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Ongoing Class I Medical devices
- Recall started
- 7 August 2024
- Reason
- Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
- Distribution
- US distribution to AL, CA, GA, IL, MI, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2972-2024
- Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Ongoing Class I Drugs
- Recall started
- 24 July 2024
- Reason
- Presence of Particulate Matter
- Distribution
- Nationwide within U.S.A
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0638-2024
- 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Ongoing Class II Medical devices
- Recall started
- 17 June 2024
- Reason
- Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2404-2024, Z-2392-2024, Z-2380-2024, Z-2390-2024, Z-2391-2024, Z-2395-2024, Z-2386-2024, Z-2384-2024, Z-2389-2024, Z-2388-2024, Z-2383-2024, Z-2381-2024 and 17 more
- OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
- Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
- Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
- Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
- Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
- Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
- Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
- Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
- and 21 more product lines
Ongoing Class II Medical devices
- Recall started
- 14 June 2024
- Reason
- Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
- Distribution
- Domestic distribution nationwide. International distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2434-2024, Z-2435-2024, Z-2436-2024, Z-2433-2024, Z-2437-2024
- Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Compon
- Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
- Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
- Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
- Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
Ongoing Class II Medical devices
- Recall started
- 17 May 2024
- Reason
- The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2131-2024, Z-2132-2024, Z-2134-2024, Z-2133-2024
- Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
- Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
- Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
- Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Terminated Class II Drugs
- Recall started
- 22 March 2024
- Terminated
- 1 July 2025
- Reason
- Lack of assurance of sterility: bags have the potential to leak..
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0431-2024
- Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Terminated Class II Drugs
- Recall started
- 6 March 2024
- Terminated
- 16 April 2025
- Reason
- Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0370-2024
- Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Ongoing Class II Medical devices
- Recall started
- 22 January 2024
- Reason
- Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1150-2024, Z-1149-2024
- Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the
- Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or
Ongoing Class I Medical devices
- Recall started
- 1 November 2023
- Reason
- In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
- Distribution
- Distribution US nationwide, Canada and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0355-2024
- Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP S
Ongoing Class II Medical devices
- Recall started
- 26 September 2023
- Reason
- Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0132-2024, Z-0133-2024, Z-0131-2024, Z-0130-2024, Z-0135-2024, Z-0134-2024, Z-0128-2024, Z-0129-2024, Z-0136-2024
- TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
- THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
- 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
- AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
- ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
- FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
- SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
- and 1 more product lines
Ongoing Class I Medical devices
- Recall started
- 21 September 2023
- Reason
- Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0123-2024, Z-0124-2024
- 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Ongoing Class II Medical devices
- Recall started
- 7 August 2023
- Reason
- The sterile blister packaging may be damaged, and sterility may be compromised
- Distribution
- US Nationwide distribution in the state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2644-2023, Z-2643-2023
- B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive,
- B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virgi
Terminated Class III Drugs
- Recall started
- 2 August 2023
- Terminated
- 7 July 2025
- Reason
- Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1083-2023
- 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Ongoing Class II Medical devices
- Recall started
- 31 July 2023
- Reason
- Product may be mislabeled with an incorrect lid stock label.
- Distribution
- US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2627-2023
- Perifix¿ / Epidural anesthesia set, medicated
Terminated Class II Drugs
- Recall started
- 5 July 2023
- Terminated
- 23 April 2024
- Reason
- Lack of assurance of sterility: bags have the potential to leak.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0916-2023
- 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Ongoing Class II Medical devices
- Recall started
- 5 June 2023
- Reason
- Kits were assembled with the incorrect Filter Straw.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2003-2023, Z-2002-2023
- Design Options¿ / Epidural anesthesia kit (10 count carton)
- Perifix¿ / Epidural anesthesia kit (10 count carton)
Terminated Class II Drugs
- Recall started
- 9 May 2023
- Terminated
- 14 March 2024
- Reason
- Subpotent: Low anti-factor IIa Potency.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0579-2023
- Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Terminated Class II Drugs
- Recall started
- 1 March 2023
- Terminated
- 13 March 2024
- Reason
- Subpotent Drug: low Anti-Factor IIa potency.
- Distribution
- Nationwide in the USA
- Recall number
- D-0434-2023
- Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
Completed Class II Drugs
- Recall started
- 10 February 2023
- Reason
- Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
- Distribution
- USA Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0347-2023, D-0346-2023
- 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
- 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Terminated Class II Drugs
- Recall started
- 25 November 2022
- Terminated
- 23 August 2024
- Reason
- Lack of sterility assurance: Bags have the potential to leak.
- Distribution
- FL, NJ, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0076-2023
- 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Ongoing Class II Medical devices
- Recall started
- 15 September 2022
- Reason
- The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
- Distribution
- Distribution US nationwide, Canada and Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0092-2023, Z-0090-2023, Z-0091-2023
- CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
- ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
- Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male l
Ongoing Class II Medical devices
- Recall started
- 1 September 2022
- Reason
- Potential for leakage at the catheter hub.
- Distribution
- Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0009-2023
- Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Terminated Class II Drugs
- Recall started
- 25 February 2022
- Terminated
- 16 March 2023
- Reason
- Lack of sterility assurance: leaking bags
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0655-2022
- 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Terminated Class II Medical devices
- Recall started
- 7 February 2022
- Terminated
- 28 December 2023
- Reason
- Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
- Distribution
- US Distribution to states of: MA, VT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0819-2022
- PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Terminated Class II Medical devices
- Recall started
- 31 January 2022
- Terminated
- 29 April 2024
- Reason
- This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0727-2022
- Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Terminated Class II Medical devices
- Recall started
- 28 January 2022
- Terminated
- 15 May 2024
- Reason
- Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0873-2022, Z-0872-2022
- Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dial
- Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dial
Terminated Class II Medical devices
- Recall started
- 10 August 2021
- Terminated
- 16 September 2024
- Reason
- Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2555-2021, Z-2549-2021, Z-2544-2021, Z-2559-2021, Z-2557-2021, Z-2552-2021, Z-2553-2021, Z-2547-2021, Z-2560-2021, Z-2550-2021, Z-2548-2021, Z-2551-2021 and 5 more
- PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
- Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
- 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
- Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
- OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
- OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
- Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
- 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 25 June 2021
- Terminated
- 16 October 2023
- Reason
- There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
- Distribution
- Affected products were distributed to the following US states: CA, MI, OR, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2137-2021
- Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Terminated Class II Medical devices
- Recall started
- 15 March 2021
- Terminated
- 7 June 2022
- Reason
- BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
- Distribution
- US Nationwide distribution in the states of NC, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1509-2021
- Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, cont
Terminated Class II Medical devices
- Recall started
- 23 November 2020
- Terminated
- 14 March 2023
- Reason
- There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0718-2021, Z-0717-2021, Z-0719-2021
- APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
- APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
- APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Terminated Class I Drugs
- Recall started
- 18 April 2020
- Terminated
- 21 October 2021
- Reason
- Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
- Distribution
- Product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1257-2020
- Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Terminated Class II Medical devices
- Recall started
- 20 November 2019
- Terminated
- 16 October 2020
- Reason
- Potential for leakage at the joint between the blood filters and tubing
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0938-2020, Z-0936-2020, Z-0939-2020, Z-0937-2020, Z-0941-2020, Z-0940-2020, Z-0935-2020
- Y-Type Blood Set, Catalog Number 490425
- Y-Type Blood Set, Catalog Number 490293
- Y-Type Blood Set, Catalog Number 490530
- Y-Type Blood Set, Catalog Number 490314
- Safeline Y-Type Blood Set, Catalog Number V2500
- Safeline Y-Type Blood Set, Catalog Number NF5140
- Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Terminated Class II Medical devices
- Recall started
- 10 July 2019
- Terminated
- 21 August 2020
- Reason
- The filter capacity is not achieved due to damage of the filter membrane.
- Distribution
- CA FL MO TX MN AL GA NC IL PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2470-2019, Z-2466-2019, Z-2471-2019, Z-2474-2019, Z-2472-2019, Z-2469-2019, Z-2473-2019, Z-2468-2019, Z-2467-2019
- CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
- ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
- CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
- CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
- CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
- CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
- CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
- FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
- and 1 more product lines
Terminated Class II Drugs
- Recall started
- 13 June 2019
- Terminated
- 15 July 2022
- Reason
- Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1343-2019
- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
Terminated Class I Medical devices
- Recall started
- 1 May 2019
- Terminated
- 13 July 2020
- Reason
- Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
- Distribution
- Distribution to US state of TX, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2489-2019
- B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Terminated Class II Medical devices
- Recall started
- 20 July 2018
- Terminated
- 13 May 2020
- Reason
- The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3341-2018, Z-3345-2018, Z-3314-2018, Z-3331-2018, Z-3370-2018, Z-3367-2018, Z-3383-2018, Z-3316-2018, Z-3343-2018, Z-3356-2018, Z-3361-2018, Z-3320-2018 and 81 more
- CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for
- CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delive
- CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for de
- CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for
- CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for
- CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for d
- EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for d
- CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter fo
- and 85 more product lines
Terminated Class II Medical devices
- Recall started
- 4 June 2018
- Terminated
- 13 January 2020
- Reason
- There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.
- Distribution
- The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2343-2018
- 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Terminated Class II Medical devices
- Recall started
- 9 May 2018
- Terminated
- 12 December 2019
- Reason
- There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
- Distribution
- US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2285-2018
- Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a lat
Terminated Class II Drugs
- Recall started
- 16 February 2018
- Terminated
- 23 January 2020
- Reason
- Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0549-2018
- 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Terminated Class II Medical devices
- Recall started
- 21 June 2017
- Terminated
- 3 April 2018
- Reason
- B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0573-2018, Z-0567-2018, Z-0570-2018, Z-0572-2018, Z-0568-2018, Z-0571-2018, Z-0574-2018, Z-0569-2018, Z-0575-2018, Z-0576-2018
- Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- and 2 more product lines
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.