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.

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DateProductReasonClassFirm
Feb 11, 2026 BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... Class II CareFusion 303, Inc.
Dec 3, 2025 BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1... Due a software issue that may result in equipment not receiving timely updates of patient, medica... Class II CareFusion 303, Inc.
Nov 20, 2025 BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar... Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca... Class II CareFusion 303, Inc.
Nov 6, 2025 BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar... Due to a number of modules flashed with a date and time associated with the daylight savings time... Class II CareFusion 303, Inc.
Oct 17, 2025 BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF... If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, wh... Class I CareFusion 303, Inc.
Sep 30, 2025 Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 11... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-0... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 BD Pyxis Pro MedStation Main, REF: 1155-00 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 11, 2025 BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ... Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
Jul 10, 2025 Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... Reports of delayed access to medication in automated dispensing cabinets because of the override/... Class III CareFusion 303, Inc.
Jul 8, 2025 BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
Jul 8, 2025 BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B... Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
May 8, 2025 BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400... Antivirus software was not consistently installed on impacted devices during the implementation p... Class II CareFusion 303, Inc.
May 8, 2025 Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P... During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in... Class II CareFusion 303, Inc.
Mar 11, 2025 BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e... Class II CareFusion 303, Inc.
Mar 11, 2025 BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r... Class II CareFusion 303, Inc.
Mar 11, 2025 BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie... Class II CareFusion 303, Inc.
Feb 18, 2025 BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 18, 2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 6, 2025 BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... Sync timeout may occur between the server and automated dispensing device, due to a server softwa... Class II CareFusion 303, Inc.
Jan 23, 2025 BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The B... Due to fingerprint scanner failing resulting in the scanner heating up. Class II CareFusion 303, Inc.
Jan 23, 2025 BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite ... Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in th... Class II CareFusion 303, Inc.
Jan 10, 2025 BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... Automated dispensing device labeling is being updated to strengthen labeling around manual access... Class II CareFusion 303, Inc.
Jan 8, 2025 (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... Class II CareFusion 303, Inc.
Jan 8, 2025 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... Software issues could potentially result in: 1) delays in accessing dispensing software applicati... Class II CareFusion 303, Inc.
Nov 14, 2024 BD Pyxis MedStation ES, REF: 323 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Nov 14, 2024 BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Nov 14, 2024 BD Pyxis CII Safe ES, REF: 1116-00 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Jul 9, 2024 BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... 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-3FM-P, REF: 169-99 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-2FH-1FM-P, REF: 169-97 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-14HH-P, REF: 169-86 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 MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 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-6HH-4FM-P, REF: 169-94 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-2FH-2FM-P, REF: 169-93 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-4HH-P, REF: 169-115 containing software version 3.9.1.9 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-6FM, REF: 169-89 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 MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 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.

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.