Class IIOngoingZ-1137-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Recalls in New York
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 80 recalls
Class IIIOngoingZ-0538-2026
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials design…
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16.…
POLYMEDCO, INC. / POLY…NYNov 26, 2025
Class IIOngoingZ-0038-2026
ImaCor Inc. recalls ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TE…
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
ImaCor Inc.NYOct 15, 2025
Class IIOngoingZ-2608-2025
CooperVision, Inc. recalls Voyant 1-Day Premium Toric
One lot manufactured with an invalid sterilization cycle.
CooperVision, Inc.NYOct 1, 2025
Class IIOngoingZ-2607-2025
CooperVision, Inc. recalls Sofmed Breathables
One lot manufactured with an invalid sterilization cycle.
CooperVision, Inc.NYOct 1, 2025
Class IIOngoingZ-2606-2025
CooperVision, Inc. recalls MyDay Toric
One lot manufactured with an invalid sterilization cycle.
CooperVision, Inc.NYOct 1, 2025
Class IIOngoingZ-2560-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J du…
Ortho-Clinical Diagnos…NYSep 24, 2025
Class IIOngoingZ-2559-2025
Ortho-Clinical Diagnostics, Inc. recalls Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartr…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J du…
Ortho-Clinical Diagnos…NYSep 24, 2025
Class IIOngoingZ-2542-2025
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Siemens Healthcare Dia…NYSep 17, 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-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-2276-2025
Intersurgical Inc recalls One-piece Guedel airway
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Intersurgical IncNYAug 13, 2025