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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
Dec 19, 2018 Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340... Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Dec 19, 2018 Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-987... Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Aug 6, 2018 Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene mal... Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal b... Class II Reckitt Benckiser LLC
Jul 23, 2018 Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 0234... The products failed the filed specification of 1.0kPa for Burst Pressure. Class II Reckitt Benckiser LLC
Nov 22, 2016 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the... Class II Reckitt Benckiser 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.