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 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
Apr 12, 2019 Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.m... When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... Class II Geistlich Pharma North America, Inc.
Apr 12, 2019 Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.m... When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... Class II Geistlich Pharma North America, Inc.
Apr 12, 2019 Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.... When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the oute... Class II Geistlich Pharma North America, Inc.
Apr 10, 2019 MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ10... BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of... Class II Becton Dickinson & Company
Apr 8, 2019 MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniT... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS902... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System ... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Mar 31, 2019 Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra ... Stability did not meet acceptance criteria for visual appearance during mixing and force vs. disp... Class II Integra Limited
Mar 20, 2019 Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes Class III GETINGE US SALES LLC
Mar 19, 2019 Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model):... Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead ... Class II Collagen Matrix, Inc.
Mar 12, 2019 VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 12, 2019 VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTU... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 12, 2019 PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 8, 2019 Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right,... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.

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.