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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 13, 2023 BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walkin... Due to walkers not meeting product specifications. Walkers were manufactured with misaligned whe... Class II Breg Inc
Mar 30, 2017 If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products ar... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Rect L, P/N 02428 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr, P/N 04908 Product Usage: These products are sterile dress... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Back, P/N 09810 Product Usage: These products are sterile dressi... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dr... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 14, 2014 K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The prod... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... Class II Breg Inc
Mar 14, 2014 Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usa... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... Class II Breg Inc
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Aug 11, 2010 Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold th... This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli... Class II Breg Inc, An Orthofix Company

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.