Browse Device Recalls
2,093 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,093 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 2,093 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catal... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tu... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 5, 2019 | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.... | The monitor displays an error message . The error message states "internal error restart or serv... | Class II | GETINGE US SALES LLC |
| Jun 3, 2019 | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 3... | The products have been confirmed to have reduced or no additive within the tube reservoir. The t... | Class II | Becton Dickinson & Company |
| May 30, 2019 | BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 3... | Lot has been confirmed to have no additive within the tube. Sample processed without the preserva... | Class II | Becton Dickinson & Company |
| May 28, 2019 | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Pa... | The device was distributed with the outer carton labeled with the manufacture date and the expiry... | Class II | Datascope Corporation |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:V... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: V... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:V... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VL... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VL... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 13, 2019 | BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inh... | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Nu... | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer SST Part/Catalog No.365967 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer SST- Amber Part/Catalog Number: 365978 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 6, 2019 | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294,... | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment... | Class I | Becton Dickinson & Company |
| May 6, 2019 | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 ... | User may suffer an electric shock when coming in contact with the exposed electronic components | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 2, 2019 | CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displace... | After disconnection of a luer, the valve of the connector remains recessed; not fully closing, ei... | Class II | Becton Dickinson & Company |
| Apr 19, 2019 | ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Pr... | Possibility that a suture raw material containing high endotoxin levels was used in the manufact... | Class II | Ethicon, Inc. |
| Apr 19, 2019 | ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 ... | Possibility that a suture raw material containing high endotoxin levels was used in the manufact... | Class II | Ethicon, Inc. |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 30300 Material:701052623 | 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 Pack Material:701054438R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417 | 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.