Class IIOngoingZ-2423-2025
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical, Inc.NJSep 3, 2025
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 721–732 of 1,125 recalls
Class IIOngoingZ-2422-2025
Dentsply IH, Inc. recalls Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number:…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
Dentsply IH, Inc.MASep 3, 2025
Class IIOngoingZ-2421-2025
Dentsply IH, Inc. recalls Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Numbe…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
Dentsply IH, Inc.MASep 3, 2025
Class IIOngoingZ-2420-2025
MAQUET GMBH recalls Corin Operating Tables Model Numbers: (1) 770001A0
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from perfor…
MAQUET GMBHSep 3, 2025
Class IIOngoingZ-2335-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Ca Slides
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay cal…
Ortho-Clinical Diagnos…NYAug 27, 2025
Class IIOngoingZ-2331-2025
Spiggle & Theis Mt Gmbh recalls Injection needle
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Spiggle & Theis Mt Gmb…Aug 27, 2025
Class IIOngoingZ-2322-2025
Beckman Coulter, Inc. recalls Access Thyroglobulin assay
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropr…
Beckman Coulter, Inc.MNAug 20, 2025
Class IIOngoingZ-2292-2025
Trinity Biotech USA recalls Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnost…
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Trinity Biotech USANYAug 20, 2025
Class IIOngoingZ-2289-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Plastic Trial Head Brown
Inconsistent size terminology and color coding used on labeling
Waldemar Link GmbH & C…Aug 20, 2025
Class IIOngoingZ-2288-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Prosthesis Head B
Inconsistent size terminology and color coding used on labeling
Waldemar Link GmbH & C…Aug 20, 2025
Class IIOngoingZ-2272-2025
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…
Siemens Healthcare Dia…MAAug 13, 2025
Class IIOngoingZ-2263-2025
AVID Medical, Inc. recalls ROBOTIC URO/GYN PACK. Medical convenience kit.
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
AVID Medical, Inc.VAAug 13, 2025