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 |
|---|---|---|---|---|
| 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. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties a... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CO... | 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 1X6-200 Model/Catalog Number: 801453. The surgical patties and sur... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and ... | 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 3-1/2X6 Model/Catalog Number:801457. 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. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and ... | 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 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... | 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 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... | 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 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgi... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties an... | 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 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... | 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 1/2X6 Model/Catalog Number: 801451. 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. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 3X3 Model/Catalog Number: 801409. 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 1-1/2X6 Model/Catalog Number: 801454. 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 | VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. | Class I | Maquet Cardiovascular, LLC |
| Sep 20, 2024 | SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 17, 2024 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... | There is discrepant labeling on the inner and outer packaging of the device. | Class II | Datascope Corp. |
| Sep 17, 2024 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended ... | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in th... | Class II | Topcon Medical Systems, Inc. |
| Sep 13, 2024 | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. | Class II | Integra LifeSciences Corp. |
| Sep 13, 2024 | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... | Class III | DRG International, 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.