Recall Atlas
Drugs & medicalClass II

CooperVision, Inc. recalls Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables…

The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement…

Read the official notice →
Date
2026-10-28
Country
United States
Brand
CooperVision
Product
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables…
Classification
Class II
Units
US Nationwide distribution in the states of FL, KY, MI.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More CooperVision recalls

  1. 2026-09-30
  2. Drugs & medicalClass II

    CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

    A small number of lenses within the affected lot are of the incorrect power.

    FDA · DeviceCooperVision, Inc.US Nationwide distribution in the states of MN, OH, WI.Official notice →
  3. 2025-10-01
  4. Drugs & medicalClass II

    CooperVision, Inc. recalls MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel,…

    One lot manufactured with an invalid sterilization cycle.

    FDA · DeviceCooperVision, Inc.US Nationwide distribution in the states of Florida, Kentucky, North Carolina,…Official notice →
  5. 2025-07-30
  6. Drugs & medicalClass II

    CooperVision, Inc. recalls Biofinity XR Toric Contact Lens

    Lens blisters may have an incomplete or leaking seal which may render them unsterile.

    FDA · DeviceCooperVision, Inc.Worldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice →
  7. 2025-04-02
  8. Drugs & medicalClass II

    CooperVision, Inc. recalls Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For…

    a limited number of lots were manufactured with an incorrect cylinder power.

    FDA · DeviceCooperVision, Inc.Domestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA.…Official notice →
  9. 2024-10-09
  10. Drugs & medicalClass II

    CooperVision, Inc. recalls Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism)…

    Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

    FDA · DeviceCooperVision, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →
  11. 2023-03-29
  12. Drugs & medicalClass II

    CooperVision, Inc. recalls Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

    The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

    FDA · DeviceCooperVision, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and…Official notice →
All 9 CooperVision recalls →

Other drugs & medical recalls in the United States

  1. 2026-10-28
  2. Drugs & medicalClass II

    Boston Scientific Cork, Ltd. recalls Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

    The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser…

    FDA · DeviceBoston Scientific Cork, Ltd.Worldwide distribution US Nationwide and territory of Puerto Rico. The…Official notice →
  3. Drugs & medicalClass II

    Life Technologies Holdings Pte Ltd recalls Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer

    DNA or RNA sequencing system software has vulnerabilities.

    FDA · DeviceLife Technologies Holdings Pte LtdUS Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ,…Official notice →
  4. Drugs & medicalClass II

    TECHNO-PATH MANUFACTURING LTD. recalls Techno-Path Multichem AE Unassayed Level 2 REF: AE622X

    A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life…

    FDA · DeviceTECHNO-PATH MANUFACTURING LTD.US Nationwide distribution in the state of Massachusetts.Official notice →
  5. Drugs & medicalClass II

    Medtronic MiniMed, Inc. recalls CareLink Clinic, REF: MMT-7350

    CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily…

    FDA · DeviceMedtronic MiniMed, Inc.US Nationwide distribution in the state of KS.Official notice →
  6. Drugs & medicalClass II

    Beckman Coulter, Inc. recalls ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…

    Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant…

    FDA · DeviceBeckman Coulter, Inc.US Nationwide distribution.Official notice →
  7. Drugs & medicalClass II

    Beckman Coulter, Inc. recalls ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…

    Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being…

    FDA · DeviceBeckman Coulter, Inc.US Nationwide distribution.Official notice →
See all drugs & medical recalls →