Browse Device Recalls
2,032 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,032 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 2,032 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 29, 2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endos... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 15, 2025 | Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a componen... | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... | Class I | Getinge Usa Sales Inc |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 9, 2024 | Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Dec 9, 2024 | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Oct 16, 2024 | Acrobat-i Positioner. Model Number C-XP-5000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| Oct 16, 2024 | Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| Oct 16, 2024 | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| Oct 7, 2024 | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL in... | Class II | DRG International, Inc. |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Sep 26, 2024 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | Out of specification endotoxin levels. | Class II | Integra LifeSciences Corp. |
| Sep 25, 2024 | Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc... | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned p... | Class II | Ethicon, Inc. |
| Sep 22, 2024 | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL... | Potential challenge with intraoperative assembly of the external taper of a single midsection wit... | Class II | Onkos Surgical, Inc. |
| Sep 20, 2024 | SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and su... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surg... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | 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.