Class IIOngoingZ-1880-2025
Onkos Surgical, Inc. recalls Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Recalls in New Jersey
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 123 recalls
Class IIOngoingZ-1879-2025
Onkos Surgical, Inc. recalls a. Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1857-2025
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb S…
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1818-2025
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package.…
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1817-2025
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package.…
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1724-2025
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Integra LifeSciences C…NJMay 14, 2025
Class IOngoingZ-1717-2025
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit
Inadequate weld that can potentially cause the product to disassemble.
Integra LifeSciences C…NJMay 14, 2025
Class IOngoingZ-1716-2025
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator
Inadequate weld that can potentially cause the product to disassemble.
Integra LifeSciences C…NJMay 14, 2025
Class IIOngoingZ-1622-2025
Maquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conju…
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device.…
Maquet Cardiovascular,…NJApr 30, 2025
Class IIOngoingZ-1577-2025
Maquet Cardiovascular, LLC recalls Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasovi…
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Maquet Cardiovascular,…NJApr 23, 2025
Class IIOngoingZ-1491-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Class IIOngoingZ-1490-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025