Browse Device Recalls
164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 164 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| May 21, 2024 | BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units | Due to a software issue the PC unit may not connect to the server which could impact wireless dat... | Class II | CareFusion 303, Inc. |
| May 13, 2024 | BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN ... | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... | Class II | CareFusion 303, Inc. |
| May 13, 2024 | BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH ME... | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... | Class II | CareFusion 303, Inc. |
| May 2, 2024 | BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; An... | If automated dispensing cabinets have specific software versions, and Component Manager was confi... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation ES, REF: 323, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis" Anesthesia Station ES, REF: 327 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis(TM) Anesthesia Station 4000, REF: 338 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and di... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense m... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 1, 2024 | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... | Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... | Class II | CareFusion 303, Inc. |
| Oct 5, 2023 | MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00;... | If "Clear All" selected medications is selected on patient profile, the automated dispensing cabi... | Class II | CareFusion 303, Inc. |
| Sep 15, 2023 | BD Alaris PCU REF 8015 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | BD Alaris Syringe Module, REF 8110 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | Alaris PCA Module 8120 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 6, 2023 | BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wi... | When global edit is used to update multiple formulary properties simultaneously, the following pr... | Class II | CareFusion 303, Inc. |
| Aug 18, 2023 | BD Pyxis MedBank MedPass Software, REF: 139088-01 | After dispensing a timed dose medication for a patient, the automated dispensing cabinet software... | Class II | CareFusion 303, Inc. |
| May 22, 2023 | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... | Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... | Due to an automated dispensing cabinet software issue, when a medication single order contains mo... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX, REF 324 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 AUX, REF 306 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES (Med ES Main), REF 323 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 Main, REF 303 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX To... | Due to an increase in complaints of door latch assembly failures that may cause the doors to be l... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med... | Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis Med 4000 Auxiliary (AUX), REF 314 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis Med ES Auxiliary (AUX), REF 343 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Jan 24, 2023 | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car... | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con... | Class II | CareFusion 303, Inc. |
| Dec 12, 2022 | BD Pyxis MedBank System - Product Label/labeling pending | Due to customer complaints related to the MedBank software which may indicate that a different me... | Class II | CareFusion 303, Inc. |
| May 24, 2022 | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... | The automated dispensing cabinet software update included a .dll file that is not compatible with... | Class II | CareFusion 303, Inc. |
| Mar 3, 2021 | BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module... | Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module contin... | Class I | CareFusion 303, Inc. |
| Aug 4, 2020 | PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ... | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... | Class I | CareFusion 303, Inc. |
| Aug 4, 2020 | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari... | The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in... | Class I | CareFusion 303, Inc. |
| Aug 4, 2020 | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, ... | Infusion pump component defect may result in interruption of patient monitoring | Class II | CareFusion 303, Inc. |
| Aug 4, 2020 | Alaris System PC Unit Model 8015 | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... | Class I | CareFusion 303, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.