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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.

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DateProductReasonClassFirm
May 6, 2020 Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A... A material weakness adjacent to the polymer fill channel may become compromised during pressuriza... Class I Endologix, Inc.
Jul 31, 2018 ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jan 4, 2017 AFX Endovascular AAA System Item Number Item Description F0070305 ... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Jan 4, 2017 AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcate... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Sy... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Endologix initiated a correction by updating reports for the cumulative clinical data and informa... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX En... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcat... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcate... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
May 13, 2013 Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 107984... Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports... Class I Endologix Inc

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.