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
Apr 2, 2026 One Step UTI in vitro diagnostic test REF: 3374 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step 10A in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step pH in vitro diagnostic test REF: 31I4P The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step P in vitro diagnostic test REF: 8194 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 Uric Acid in vitro diagnostic test REF: 31H0P The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step K in vitro diagnostic test REF: 81A4 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.

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.