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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
Aug 3, 2023 GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 Some surgical glove sterile pouches were not completely sealed. Class II Ansell Healthcare Products LLC
Aug 3, 2023 NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V2... Some surgical glove sterile pouches were not completely sealed. Class II Ansell Healthcare Products LLC
Feb 19, 2022 Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene su... Transport company failed to stop at the border for required FDA inspection. Class II Ansell Healthcare Products LLC
Aug 19, 2020 MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient ... Examination gloves were shipped inadvertently, without to verify barrier integrity. Class II Ansell Healthcare Products LLC
Oct 24, 2016 Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd... Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Late... Class II Ansell Healthcare Products LLC
Jan 14, 2013 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healt... Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condo... Class II Ansell Healthcare Products LLC
Nov 5, 2012 Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of... One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was includ... Class II Ansell Healthcare Products 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.