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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Nov 5, 2025 Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ... Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje... Class II Accriva Diagnostics, Inc.
Oct 21, 2025 VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415... Due to an device without a premarket clearance being incorrectly package and distributed. Class III Accriva Diagnostics, Inc.
Dec 2, 2024 VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthc... Class II Accriva Diagnostics, Inc.
Sep 27, 2024 AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... Class II Accriva Diagnostics, Inc.
Mar 30, 2022 The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor block... Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are u... Class II Accriva Diagnostics, 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.