Class IIOngoingZ-1489-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Recalls in New Jersey
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 109–120 of 123 recalls
Class IIOngoingZ-1488-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Class IIOngoingZ-1295-2025
Integra LifeSciences Corp. recalls AURORA Surgiscope System
Possibility for the obturator to break (separate).
Integra LifeSciences C…NJMar 12, 2025
Class IIOngoingZ-1238-2025
Pentax Of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%).…
Pentax of America IncNJMar 5, 2025
Class IIOngoingZ-1237-2025
Pentax Of America Inc recalls PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a…
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%).…
Pentax of America IncNJMar 5, 2025
Class IIOngoingZ-1236-2025
Pentax Of America Inc recalls PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a…
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%).…
Pentax of America IncNJMar 5, 2025
Class IIOngoingZ-1168-2025
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/C…
Potential that the induction seal is not completely sealed to the device tube packaging.
Integra LifeSciences C…NJFeb 19, 2025
Class IIOngoingZ-1140-2025
Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model…
Device reaching End of Service prematurely.
Angel Medical Systems,…NJFeb 19, 2025
Class IOngoingZ-1074-2025
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure.…
Getinge Usa Sales IncNJFeb 19, 2025
Class IIOngoingZ-0979-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025
Class IIOngoingZ-0978-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025
Class IIOngoingZ-0977-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025