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 |
|---|---|---|---|---|
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... | Battery short-run times and unanticipated stoppage may be due to user not performing battery main... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 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 PST Gel and Lithium HeparinN (LH) 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) 158 USP Units Blood Collection Tubes, Cat... | 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 Blood Collection Tubes, Catalog Number 368035, 368036 | 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) 102 I.U. Plus 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 Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog N... | 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) 68 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 PST Gel and Lithium HeparinN (LH) 83 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 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) 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 |
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.