Browse Device Recalls

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Apr 18, 2019 Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804 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: 701053319 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 15705 Material: 701051122 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 7010524... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798 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:701047962R01 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: 701068797 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 7010539... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
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

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.