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Browse Device Recalls

62 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 62 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 62 FDA device recalls.

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DateProductReasonClassFirm
Nov 5, 2014 Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coatin... Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for ... Class II Maquet Cardiovascular Us Sales, Llc
Oct 17, 2014 Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid... Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa... Class II Maquet Cardiovascular Us Sales, Llc
Jan 31, 2014 MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat E... The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardio... Class II Maquet Cardiovascular Us Sales, Llc
Dec 5, 2013 Compressor Mini To provide a supply of dry, filtered compressed air for a ... Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. Class II Maquet Cardiovascular Us Sales, Llc
Aug 19, 2013 TEGRIS system Four labels of the Tegris System include: Emergency butt... MAQUET has identified a potential issue that might occur because of the lack of an emergency stop... Class II Maquet Cardiovascular Us Sales, Llc
Aug 15, 2013 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... The manufacturer has conducted a review of the results of product testing performed during the la... Class II Maquet Cardiovascular Us Sales, Llc
May 14, 2013 MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and ster... The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain... Class II Maquet Cardiovascular Us Sales, Llc
Apr 26, 2013 MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The... MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) ... Class II Maquet Cardiovascular Us Sales, Llc
Mar 7, 2013 Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s... When using the SERVO-i on battery power, in a very small number of cases, some battery modules di... Class I Maquet Cardiovascular Us Sales, Llc
Dec 26, 2012 Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO)... ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. Class II Maquet Cardiovascular Us Sales, Llc
Jun 12, 2012 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... It has come to firm's attention that, in some rare cases, the blood outlet connector on some mode... Class II Maquet Cardiovascular Us Sales, Llc
Feb 20, 2012 FLOW-I Anesthesia System The system is intended for use in administrating ... A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ... Class I Maquet Cardiovascular Us Sales, 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.