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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Jun 15, 2015 BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th... Class III BD Biosciences, Systems & Reagents
Mar 23, 2015 CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may... Class II BD Biosciences, Systems & Reagents
Mar 6, 2015 BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostic... The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20... Class II BD Biosciences, Systems & Reagents
Dec 19, 2014 Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for ... Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody. Class II BD Biosciences, Systems & Reagents
Dec 19, 2014 CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: ... One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and ... Class II BD Biosciences, Systems & Reagents
Jul 18, 2014 BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... Class III BD Biosciences, Systems & Reagents
Jun 6, 2014 BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer ... Laser cooling fans and internal fan of the associated fluidics cart are not operational. Class II BD Biosciences, Systems & Reagents
Apr 4, 2014 Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present i... Class II BD Biosciences, Systems & Reagents
Jun 29, 2012 BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS... Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. Class II BD Biosciences, Systems & Reagents

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.