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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 26, 2024 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 882... Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. Class II O&M HALYARD, INC.
Nov 8, 2024 O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Pro... Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... Class II O&M HALYARD, INC.
Nov 8, 2024 O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical... Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... Class II O&M HALYARD, INC.
Feb 20, 2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Product was mislabeled as a Surgical Cap at its dispenser level. Class III O&M HALYARD, INC.
Aug 9, 2023 FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOF... One respirator sample failed a filtration efficiency test. This respirator may not provide adequa... Class II O&M HALYARD, 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.