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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
Sep 10, 2019 Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revisio... The canister neck bushing may become loose and separate from the body of the canister during use.... Class II Candela Corporation
Sep 10, 2019 Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C ... The canister neck bushing may become loose and separate from the body of the canister during use.... Class II Candela Corporation
Sep 10, 2019 Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revisi... The canister neck bushing may become loose and separate from the body of the canister during use.... Class II Candela Corporation
Sep 10, 2019 Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C ... The canister neck bushing may become loose and separate from the body of the canister during use.... Class II Candela Corporation
Nov 6, 2013 Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatolo... Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch an... Class II Candela 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.