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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
Jan 30, 2025 Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog N... Firm became aware of software issues related to most recent firmware update which could result in... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
May 10, 2024 Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embeddi... An issue with safe usage of the device was identified whereby toxic smoke and internal fire devel... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Apr 10, 2024 Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent leve... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Nov 20, 2023 Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoC... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH

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.