San Diego, CA, United States
CareFusion 303, Inc. recalls
61 recalls recorded since 2018, most recently on 30 April 2026. 53 are listed as ongoing. Status and classification are as published by the FDA.
Recalls61
Ongoing (FDA)53
Terminated or completed8
Class I (FDA)14
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- Distribution
- US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TW
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2303-2026, Z-2301-2026, Z-2300-2026, Z-2298-2026, Z-2299-2026, Z-2297-2026, Z-2304-2026, Z-2302-2026
- BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
- BD Pyxis Mini Main REF: 349 Medication cabinet
- BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
- BD Pyxis MedStation ES REF: 323 Medication cabinet
- BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
- BD Pyxis MedStation 4000 REF: 303 Medication cabinet
- BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
- BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
Ongoing Class II Medical devices
- Recall started
- 11 February 2026
- Reason
- Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- Distribution
- Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S. (foreign) to countries
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1645-2026
- BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Ongoing Class II Medical devices
- Recall started
- 3 December 2025
- Reason
- Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of B
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1028-2026
- BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 1
Ongoing Class II Medical devices
- Recall started
- 20 November 2025
- Reason
- Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
- Distribution
- Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO, MA, ID, WV, DE, PA, WA, MT, CT, IA, MD, PR, MN, NM, OR, VT, MS, ME, AK, UT, DC, GU, SC, NH, RI, ND, AS and the countries
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0962-2026
- BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with
Ongoing Class II Medical devices
- Recall started
- 6 November 2025
- Reason
- Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
- Distribution
- U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1217-2026
- BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of flu
Ongoing Class I Medical devices
- Recall started
- 17 October 2025
- Reason
- If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0430-2026
- BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Insp
Ongoing Class II Medical devices
- Recall started
- 30 September 2025
- Reason
- Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0370-2026, Z-0368-2026, Z-0369-2026, Z-0371-2026, Z-0367-2026
- BD Pyxis Pro MedStation Main, REF: 1155-00
- Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139
- Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
- All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
- Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-0
Ongoing Class I Medical devices
- Recall started
- 11 September 2025
- Reason
- Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
- Distribution
- US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore Taiwan, Province of China South Africa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0035-2026
- BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Buret
Ongoing Class III Medical devices
- Recall started
- 10 July 2025
- Reason
- Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
- Distribution
- US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH, FL, WA, MS, OK, TN, PA, RI, TX, SC, AR, MI, NJ, CT, MD, AZ, CA, WV, NC, UT, WY, CO, SD, ID, IL, IN, NV, NM, NE, KS, GA, WI, MO, IA, ME, LA, MN, AL, VT, NH, DE, MT, ND, AK, HI, DC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2321-2025
- Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXI
Ongoing Class I Medical devices
- Recall started
- 8 July 2025
- Reason
- Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
- Distribution
- US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL 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 PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2180-2025, Z-2179-2025
- BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Ongoing Class II Medical devices
- Recall started
- 8 May 2025
- Reason
- During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
- Distribution
- Worldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries o
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2017-2025
- Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesi
Ongoing Class II Medical devices
- Recall started
- 8 May 2025
- Reason
- Antivirus software was not consistently installed on impacted devices during the implementation process.
- Distribution
- Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2477-2025
- BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 32
Ongoing Class II Medical devices
- Recall started
- 11 March 2025
- Reason
- Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
- Distribution
- US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL, KS, MI, IN, MN, MT, KY, MO, UT, NJ, OH, PA, ND, OR, NE, SD, NV, OK, GA, MA, IA, HI, ME, AZ, IL, SC, LA, WV, AL, ID, NM, DC, NH, VT, CT, MD, AR, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1545-2025
- BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorize
Ongoing Class II Medical devices
- Recall started
- 11 March 2025
- Reason
- Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
- Distribution
- U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1550-2025
- BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01
Ongoing Class II Medical devices
- Recall started
- 11 March 2025
- Reason
- Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
- Distribution
- US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR, AZ, CO, ND, GA, NE, TX, IL, OH, VT, IN, TN, KY, IA, MT, NY, CA, UT, OK, SD, WA, AK, ME, NV, NM, NC, WV, LA, MN, ID, AL, VA, WI, NH, KS, MA, CT, RI, NJ, MD, MS, WY, DC, DE, HI, AR, ON.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1639-2025
- BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-1
Ongoing Class I Medical devices
- Recall started
- 18 February 2025
- Reason
- Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
- Distribution
- US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1304-2025, Z-1305-2025
- BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
- BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Ongoing Class II Medical devices
- Recall started
- 6 February 2025
- Reason
- Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
- Distribution
- Worldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1375-2025
- BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-
Ongoing Class II Medical devices
- Recall started
- 23 January 2025
- Reason
- Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1231-2025
- BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonat
Ongoing Class II Medical devices
- Recall started
- 23 January 2025
- Reason
- Due to fingerprint scanner failing resulting in the scanner heating up.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1207-2025
- BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and a
Ongoing Class II Medical devices
- Recall started
- 10 January 2025
- Reason
- Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
- Distribution
- US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1206-2025
- BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Ongoing Class II Medical devices
- Recall started
- 8 January 2025
- Reason
- Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
- Distribution
- Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1119-2025
- (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Ongoing Class II Medical devices
- Recall started
- 8 January 2025
- Reason
- Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
- Distribution
- US Nationwide distribution including in the states of AK, 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, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1227-2025, Z-1229-2025, Z-1228-2025, Z-1230-2025
- 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 13900
- 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139
- 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYX
- 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDP
Ongoing Class II Medical devices
- Recall started
- 8 January 2025
- Reason
- Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
- Distribution
- Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1120-2025
- (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxi
Ongoing Class II Medical devices
- Recall started
- 14 November 2024
- Reason
- Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- Distribution
- Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries o
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0672-2025, Z-0671-2025, Z-0670-2025
- BD Pyxis CII Safe ES, REF: 1116-00
- BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
- BD Pyxis MedStation ES, REF: 323
Ongoing Class II Medical devices
- Recall started
- 15 August 2024
- Reason
- Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3140-2024, Z-3142-2024, Z-3139-2024, Z-3138-2024, Z-3141-2024
- Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
- Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
- Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
- Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
- Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- Distribution
- US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2948-2024, Z-2947-2024
- BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
- BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Ongoing Class II Medical devices
- Recall started
- 24 June 2024
- Reason
- Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2487-2024, Z-2493-2024, Z-2495-2024, Z-2485-2024, Z-2497-2024, Z-2502-2024, Z-2490-2024, Z-2491-2024, Z-2500-2024, Z-2489-2024, Z-2496-2024, Z-2494-2024 and 7 more
- BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
- BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
- BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
- and 11 more product lines
Ongoing Class II Medical devices
- Recall started
- 21 May 2024
- Reason
- Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2262-2024
- BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Ongoing Class II Medical devices
- Recall started
- 13 May 2024
- Reason
- Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
- Distribution
- US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS, IL, FL, OK, OH, TN, GA, NM, NV, NE, TX, NC, KY, WI, SC, IA, MT, SD, VA, NJ, PA, AK, MS, MI, WA, UT, ND, MA, MN, OR, IN, WV, AL, ID, LA, CT, WY, MD, NH, AR, HI, DC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2255-2024, Z-2256-2024
- BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-
- BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145,
Ongoing Class II Medical devices
- Recall started
- 2 May 2024
- Reason
- If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.
- Distribution
- Worldwide - US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC and the countries of TW, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2374-2024
- BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC,
Ongoing Class II Medical devices
- Recall started
- 15 April 2024
- Reason
- Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, UT, VA, VT, WA, WI, WV, WY and the countries of
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1932-2024, Z-1931-2024, Z-1928-2024, Z-1927-2024, Z-1930-2024, Z-1929-2024
- BD Pyxis(TM) Anesthesia Station 4000, REF: 338
- BD Pyxis" Anesthesia Station ES, REF: 327
- BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
- BD Pyxis MedStation ES, REF: 323, Medication Cabinet
- BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
- BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
Ongoing Class II Medical devices
- Recall started
- 23 February 2024
- Reason
- Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- Distribution
- US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1125-2025, Z-1124-2025, Z-1122-2025, Z-1123-2025
- BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
- BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
- BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
- BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Ongoing Class II Medical devices
- Recall started
- 1 February 2024
- Reason
- Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of VA, SC, IL, AL, KS, LA, GA, FL, CA, PR, PA, WV, WA, HI, NC, MD, AR, NY, ND, TX, NM, GU, MS, AZ, DC, AK, NE, DE, CO, SD, MO, NJ, OK, NV, OH, KY, WY, MT, UT, ID, MA, MI, MP, NH, IA, TN, CT, RI, IN, WI, OR, MN, VT, ME and th
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1223-2024
- BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Ongoing Class II Medical devices
- Recall started
- 5 October 2023
- Reason
- If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.
- Distribution
- US Nationwide distribution in the states of KS, TX, CA, PA, NJ, FL, IN, AZ, IL, MA, NY, KY, UT, MD, WA, OH, AL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1552-2025
- MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2H
Ongoing Class I Medical devices
- Recall started
- 15 September 2023
- Reason
- Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Distribution
- Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0186-2024, Z-0185-2024, Z-0184-2024
- Alaris PCA Module 8120
- BD Alaris Syringe Module, REF 8110
- BD Alaris PCU REF 8015
Ongoing Class II Medical devices
- Recall started
- 6 September 2023
- Reason
- When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
- Distribution
- US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0093-2024
- BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 13
Ongoing Class II Medical devices
- Recall started
- 18 August 2023
- Reason
- After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.
- Distribution
- US: FL, MI, KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2646-2023
- BD Pyxis MedBank MedPass Software, REF: 139088-01
Ongoing Class II Medical devices
- Recall started
- 22 May 2023
- Reason
- Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.
- Distribution
- US Nationwide-Worldwide Distribution: CO, MS, HI, FL, GA, CA, ND, GU, DE, MO, DC, SC, VA, AK, TX, NY, MN, PA, MA, OH, WI, NC, KY, KS, IL, MD, NE, MI, IA, WA, NM, LA, OK, AZ, AR, IN, WY, AL, NJ, SD, NV, TN, OR, WV, ME, ID, CT, UT, RI, MT, PR, NH, VT, AS OUS: GU, KW, AE, SA, NZ, CA, BE ,GB, IT, JP, K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2094-2023
- BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Softwar
Ongoing Class II Medical devices
- Recall started
- 5 April 2023
- Reason
- Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.
- Distribution
- US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1579-2023
- BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop
Ongoing Class II Medical devices
- Recall started
- 5 April 2023
- Reason
- Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
- Distribution
- US Nationwide distribution in the states of NY, NC, LA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0906-2025
- BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.
- Distribution
- Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1207-2023
- BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0975-2025, Z-0973-2025, Z-0976-2025, Z-0971-2025, Z-0974-2025, Z-0972-2025
- BD Pyxis Med ES Auxiliary (AUX), REF 343
- BD Pyxis MedStation 4000 Main, REF 303
- BD Pyxis Med 4000 Auxiliary (AUX), REF 314
- BD Pyxis MedStation ES (Med ES Main), REF 323
- BD Pyxis MedStation 4000 AUX, REF 306
- BD Pyxis MedStation ES AUX, REF 324
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1050-2025
- BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely sto
Ongoing Class II Medical devices
- Recall started
- 24 January 2023
- Reason
- Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed
- Distribution
- US: FL, CA, OR, IL, WI, NJ, AZ, NV, CO, WY, NE, TX, MI, VA, OH, NC, LA, NM, AL, TN, AR, PA, CT, IN, KS, GA, SC, MD, UT, MA, DC, OK, IA, NY, WA, SD, ND, MN, KY, MO, WV, MS, DE, ME, MT, ID, NH, HI, AK, VT OUS: Canada, Qatar, Saudi Arabia,, Kuwait, United Arab Emirates, Israel, South Africa, Zimbabwe,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1192-2023
- Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Ongoing Class II Medical devices
- Recall started
- 12 December 2022
- Reason
- Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.
- Distribution
- U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0928-2023
- BD Pyxis MedBank System - Product Label/labeling pending
Ongoing Class II Medical devices
- Recall started
- 24 May 2022
- Reason
- The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop opening in the MedBank Application) leading to delay in access to medications or supplies needed in residential or procedural care facilities.
- Distribution
- U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME,. MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1785-2022
- BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating
Ongoing Class I Medical devices
- Recall started
- 3 March 2021
- Reason
- Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
- Distribution
- Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1309-2021
- BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Ongoing Class I Medical devices
- Recall started
- 4 August 2020
- Reason
- Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
- Distribution
- Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hu
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2939-2020
- BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Ongoing Class I Medical devices
- Recall started
- 4 August 2020
- Reason
- The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
- Distribution
- U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, Z
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2909-2020, Z-2910-2020
- Alaris System PC Unit Model 8015
- PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPA
Ongoing Class I Medical devices
- Recall started
- 4 August 2020
- Reason
- The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
- Distribution
- US - AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY OUS - AE, AU, BE, BH, CA, CH, CN, IN, KW, MX, MY, NL, NZ, PH, QA, SA, TW and
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2882-2020
- BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Ongoing Class II Medical devices
- Recall started
- 4 August 2020
- Reason
- Infusion pump component defect may result in interruption of patient monitoring
- Distribution
- U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2935-2020
- BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 mod
Terminated Class I Medical devices
- Recall started
- 30 June 2020
- Terminated
- 22 April 2024
- Reason
- Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
- Distribution
- Worldwide distribution. US nationwide including Guam, Puerto Rico, American Samoa, and Military Pacific. Countries of: TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, and BH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2717-2020, Z-2718-2020, Z-2721-2020, Z-2723-2020, Z-2722-2020, Z-2716-2020, Z-2720-2020, Z-2719-2020
- Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
- Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
- Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
- Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
- Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
- Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
- Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
- Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Terminated Class I Medical devices
- Recall started
- 30 June 2020
- Terminated
- 22 April 2024
- Reason
- If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.
- Distribution
- U.S.: CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, KS, MN, MI, WA, UT, MD, TN, CO, NJ, NE, ND, WV, KY, IA, MS, AL, DE, AK, VA, OK, NM, GA, CT, SD, NV, ID, MT, ME, VT, WY, NH, MP, DC, GU, PR, AS, RI. O.U.S.: TR, QA, CA, AE, KW, MX, IL, SA, CH, NL, BE, TW, ZA, PH, CN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2741-2020, Z-2740-2020
- Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
- Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Ongoing Class II Medical devices
- Recall started
- 30 June 2020
- Reason
- LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2823-2020, Z-2822-2020, Z-2826-2020, Z-2825-2020, Z-2824-2020
- Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to
- Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to ent
- Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps n
- Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to en
- Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to ente
Terminated Class I Medical devices
- Recall started
- 30 June 2020
- Terminated
- 23 April 2024
- Reason
- Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
- Distribution
- US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2736-2020
- Alaris Pump Module Model 8100
Ongoing Class I Medical devices
- Recall started
- 4 February 2020
- Reason
- 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
- Distribution
- Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1359-2020, Z-1362-2020, Z-1360-2020, Z-1361-2020
- CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
- CareFusion Alaris PCA Module, Model 8120
- CareFusion Alaris Pump Module, Model 8100
- CareFusion Alaris Syringe Module, Model 8110
Terminated Class II Medical devices
- Recall started
- 1 July 2019
- Terminated
- 9 September 2020
- Reason
- Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
- Distribution
- US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2443-2019
- Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Terminated Class II Medical devices
- Recall started
- 20 April 2018
- Terminated
- 10 February 2021
- Reason
- Complaints where users were unable to prime the administration set.
- Distribution
- Worldwide Distribution - US Nationwide including Guam International: Canada, Australia, New Zealand, EU, Middel East, South Africa, Okinawa, Saipan, Buenos Aires, Lima, Selangor, Hong Kong, Taiwan, and Budapest
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0385-2019
- Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP
Terminated Class I Medical devices
- Recall started
- 13 April 2018
- Terminated
- 26 December 2023
- Reason
- The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
- Distribution
- Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY; OUS: AE, AU, BH, CA, CH, CN, GI, IL,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1768-2019
- Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured betwee
Terminated Class II Medical devices
- Recall started
- 17 November 2017
- Terminated
- 4 May 2020
- Reason
- The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0323-2018, Z-0322-2018
- Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medi
- Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers
Terminated Class II Medical devices
- Recall started
- 6 November 2017
- Terminated
- 7 December 2020
- Reason
- Reports of incorrect priming volume due to manufacturing with incorrect tubing.
- Distribution
- US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2111-2018
- Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. The
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.