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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Sep 25, 2025 Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression... Class II DJO, LLC
Sep 7, 2021 GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I DJO, LLC
Sep 7, 2021 Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I DJO, LLC
Jan 17, 2019 Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expirati... The product may not meet sterility requirements. Product labeled as sterile, however all units do... Class II DJO, LLC
Jun 25, 2018 This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and... The device accessories were not labeled with appropriate latex warning. Class II DJO, LLC
Aug 21, 2015 Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with th... Overheating and burning of the wire insulation inside the applicator. Class II DJO, LLC
May 28, 2013 VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System... DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlo... Class II DJO, LLC

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.