Class IIOngoingZ-1455-2025
CooperVision, Inc. recalls Brand Names: MyDay Toric
a limited number of lots were manufactured with an incorrect cylinder power.
CooperVision, Inc.NYApr 2, 2025
Recalls in New York
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–80 of 80 recalls
Class IIOngoingZ-1391-2025
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
Product is mislabeled with the incorrect fill volume.
Angiodynamics, Inc.NYMar 26, 2025
Class IIOngoingZ-1007-2025
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Nu…
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date.…
Ortho-Clinical Diagnos…NYJan 29, 2025
Class IIOngoingZ-1006-2025
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Numbe…
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date.…
Ortho-Clinical Diagnos…NYJan 29, 2025
Class IIOngoingZ-1005-2025
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number:…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date.…
Ortho-Clinical Diagnos…NYJan 29, 2025
Class IIOngoingZ-0902-2025
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Sli…
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
QUIDEL ORTHONYJan 22, 2025
Class IIOngoingZ-0901-2025
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Sli…
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
QUIDEL ORTHONYJan 22, 2025
Class IIOngoingZ-0770-2025
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Angiodynamics, Inc.NYJan 8, 2025