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 |
|---|---|---|---|---|
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM I... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Numb... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Ite... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Num... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Numbe... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Num... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Num... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM It... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Nu... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item ... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Numb... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number:... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM I... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-202... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Numbe... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM It... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number:... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: ... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM It... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item N... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Numbe... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 1... | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... | Class II | Linkbio Corp. |
| Mar 10, 2023 | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende... | Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produ... | Class II | Howmedica Osteonics Corp. |
| Mar 10, 2023 | VITROS 5600 Integrated System - Refurbished . For use in the in vitro quanti... | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 10, 2023 | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intende... | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produc... | Class II | Howmedica Osteonics Corp. |
| Mar 10, 2023 | VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi... | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 10, 2023 | VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-qua... | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 9, 2023 | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrator... | Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 6, 2023 | VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 | Some batches of product were not sterilized to their minimum sterilization specification. | Class II | Maquet Cardiovascular, LLC |
| Mar 6, 2023 | VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH... | Some batches of product were not sterilized to their minimum sterilization specification. | Class II | Maquet Cardiovascular, LLC |
| Mar 6, 2023 | VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 | Some batches of product were not sterilized to their minimum sterilization specification. | Class II | Maquet Cardiovascular, LLC |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) ... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 13, 2023 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ... | Class II | Maquet Medical Systems USA |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile... | Class I | Datascope 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.