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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.