Quick Facts at a Glance
- Recall Date
- August 22, 2025
- Hazard Level
- HIGH
- Brand
- CooperVision
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CooperVision
- Product type
- Toric Daily Disposable Contact Lens
- Model numbers
- Softmed Breathables, Carton Lot Number: 20735504301008, Blister Lot Number: 6450505898
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 22, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
One lot manufactured with an invalid sterilization cycle.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CooperVision, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Softmed Breathables are toric daily disposable contact lenses designed for wearers who require astigmatism correction. They use stenfilcon A material with 54 percent water content and come blister packaged for daily wear.
Why This Is Dangerous
An invalid sterilization cycle may compromise lens sterility. If sterility is compromised, wearers risk eye infections or irritation.
Industry Context
This recall is not described as part of a broader industry pattern in the available notice.
Real-World Impact
Consumers must stop using the affected lenses immediately. Eye infections can require medical care and may affect vision temporarily.
Practical Guidance
How to identify if yours is affected
- Check packaging for Carton Lot Number 20735504301008.
- Check blister packaging for Blister Lot Number 6450505898.
- If either matches, the lenses are part of the recall.
Where to find product info
Lot numbers are printed on the carton and blister packaging.
What timeline to expect
Refund or replacement timelines vary; expect 4-8 weeks for processing after approval.
If the manufacturer is unresponsive
- Contact FDA recall channels to file a consumer complaint.
- Document all correspondence with CooperVision.
- Consider seeking guidance from your eye care professional.
How to prevent similar issues
- Always verify lot numbers before using contact lenses.
- Buy lenses from reputable retailers and check recall databases regularly.
- Follow lens care and handling instructions from manufacturers.
Documentation advice
Keep the recall notice, product packaging, lot numbers, and any emails or letters from CooperVision.
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Product Details
Model numbers include Softmed Breathables with Carton Lot 20735504301008 and Blister Lot 6450505898. Distributed nationwide in Florida, Kentucky, North Carolina and Wisconsin. Quantity recalled: 180 units. Sold in blister packaging as daily disposable wear. Brand: CooperVision.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- One lot affected: Carton 20735504301008; Blister 6450505898
- States in distribution: FL, KY, NC, WI
- Hazard: invalid sterilization cycle
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Safety Guide
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