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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Feb 21, 2023 PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swa... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, RE... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety o... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7... Presence of misleading label statements on the product label. Class II Entopsis , Inc.
Feb 21, 2023 PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825... Presence of misleading label statements on the product label. Class II Entopsis , 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.