Browse Device Recalls

251 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 251 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 251 FDA device recalls.

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DateProductReasonClassFirm
Apr 18, 2019 Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardia... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 70105... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Ma... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 70105... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 22701 Material: 701050790 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Jan 24, 2019 AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mis... Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump... Class II Maquet Cardiovascular, LLC
Jan 27, 2017 VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usag... Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the d... Class II Maquet Cardiovascular, LLC
Aug 13, 2014 Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump Sys... An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the ... Class II Maquet Cardiovascular, LLC
Oct 30, 2013 Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LL... Maquet has received an increase in the number of complaints for "self-activated/remains activated... Class II Maquet Cardiovascular, LLC
Sep 20, 2013 Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use d... MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D).... Class II Maquet Cardiovascular, LLC
Mar 7, 2013 MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0... It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown... Class II Maquet Cardiovascular, 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.