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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jul 8, 2025 BD Trucount Controls, 30 Test - REF: 340335 Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... Class II Becton, Dickinson and Company, BD Bio Sciences
Jul 8, 2025 BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... Class II Becton, Dickinson and Company, BD Bio Sciences
Jun 3, 2025 REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. ... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
Jun 3, 2025 REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cy... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Aug 12, 2024 BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... Class II Becton, Dickinson and Company, BD Bio Sciences

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.