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.

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DateProductReasonClassFirm
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.