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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2018 Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DI... The device is equipped with a dial that has an inaccurate flow rate indicator. Class II Dynarex Corporation
Mar 3, 2016 dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... Class II Dynarex Corporation
Jul 2, 2014 CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynare... "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if... Class II Dynarex Corporation

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.