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 |
|---|---|---|---|---|
| Sep 2, 2025 | Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3... | The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced u... | Class II | LeMaitre Vascular, Inc. |
| Aug 28, 2025 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... | Class II | Howmedica Osteonics Corp. |
| Aug 25, 2025 | Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... | Class II | LeMaitre Vascular, Inc. |
| Aug 21, 2025 | i-STAT EG7+ cartridge. List Number: 03P76-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT EG6+ cartridge. List Number: 03P77-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 15, 2025 | Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu... | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 15, 2025 | BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001... | Potential for activation of an abnormal alarm pause. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Aug 15, 2025 | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu... | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 15, 2025 | Heartstring III Proximal Seal System. Intravascular anastomosis occluder. | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 6, 2025 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included... | Class II | Maquet Cardiovascular, LLC |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jul 21, 2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The ST... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 16, 2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c serie... | Class II | Pentax of America Inc |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal f... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAI... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED,... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jun 11, 2025 | Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous ... | Out of specification stability test result for the Caphosol B solution from process validation lots | Class II | RECORDATI RARE DISEASES INC. |
| Jun 4, 2025 | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Numbe... | An incoming complaint reported that the expiration date on the kit box label and Certificate of A... | Class III | DRG International, Inc. |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 23, 2025 | Jewel Precision Reusable Rigid Sterilization Container System. Model Number: ... | The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., mode... | Class II | Jewel Precision Sheet Metal & Machining Co, Inc. |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog ... | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility she... | Class II | Jewel Precision Sheet Metal & Machining Co, Inc. |
| May 22, 2025 | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 15 CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 21, 2025 | STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a bu... | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible... | Class II | Diagnostica Stago, Inc. |
| May 20, 2025 | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It... | Required inspections were not performed on finished product prior to release and distribution. | Class II | Onkos Surgical, Inc. |
| Apr 11, 2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14... | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 4, 2025 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Mar 20, 2025 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... | There have been at least 12 complaints from users as of March 3, 2025, reporting that they identi... | Class II | Maquet Cardiovascular, LLC |
| Mar 10, 2025 | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of ... | Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro ... | Class II | Maquet Cardiovascular, LLC |
| Feb 28, 2025 | Monterey AL Implant Inserter; 22mm; Catalog 48019140. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 6, 2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, ... | Possibility for the obturator to break (separate). | Class II | Integra LifeSciences Corp. |
| Jan 29, 2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization ... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
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.