Browse Device Recalls
352 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 352 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 352 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. |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RA... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, ... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATC... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NO... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, R... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETE... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 Inc |
| Jul 13, 2023 | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED,... | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... | Class II | Carefusion 2200 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. |
| Mar 16, 2023 | (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blad... | A portion of the two products were incorrectly marked (etched) and packaged resulting in a produc... | Class II | Carefusion 2200 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.