Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
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 NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... Potential for false negative response on the NIM Vital Nerve Monitoring System Class I Medtronic Xomed, 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 Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... Any single affected ventilator should only be used for the 10- year labelled service life, but if... Class I Covidien
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.
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.
Jun 21, 2024 ESG-410 Electrosurgical Generator- In conjunction with electrosurgical access... Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating... Class II Olympus Corporation of the Americas
Jun 20, 2024 Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireles... This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and prema... Class II Securitas Healthcare LLC
Jun 20, 2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Potential for defective test cartridges which may result in false positive results for the Staphy... Class II Luminex Corporation
Jun 20, 2024 Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery... There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and ... Class II Securitas Healthcare LLC
Jun 20, 2024 Cepheid, Sample Collection Device, Part: 900-0370 Specimen collection device may leak after the patient sample swabs have been inserted into the te... Class II Cepheid
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for... If blood culture identification panel is used in conjunction with specific lots of culture media ... Class II BioFire Diagnostics, LLC
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 18, 2024 SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... Class II Angiodynamics, Inc.
Jun 18, 2024 FoundationOne Companion Diagnostic (F1CDx) Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the d... Class II Foundation Medicine, Inc.
Jun 18, 2024 ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 KIT PEDI CRANI LAMI, Pack Number DYNJ907372A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... Class II Embecta Corp.
Jun 18, 2024 CRANIOTOMY PACK, Pack Number DYNJ46552O A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... Class II Angiodynamics, Inc.
Jun 17, 2024 Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Prod... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... Class I Megadyne Medical Products, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGA... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... Class I Megadyne Medical Products, Inc.
Jun 17, 2024 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Regard Kit containing the Microtek decanter Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. Class II ROi CPS LLC

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.