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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Oct 29, 2024 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the... Class II Smith & Nephew Inc.
Aug 12, 2024 ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ... Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... Class II Smith & Nephew Inc.
Aug 12, 2024 ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio... Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... Class II Smith & Nephew Inc.
May 24, 2024 WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation flu... Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set... Class II WOM World Of Medicine AG
Jan 9, 2014 Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS So... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s:... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dress... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Jan 9, 2014 Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 668... Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and ... Class II Smith & Nephew Inc.
Nov 14, 2013 Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew Inc.
Nov 14, 2013 Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew 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.