FDA recall, , Moderate risk
CorneaGen Cornea
Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Recall ended Sep 21, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
CorneaGen - Boston recalled corneas that were distributed in Florida and Ohio because the donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases. The recall began December 2, 2024.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Cornea
Recall details
- Company began the recall
- Company
- CorneaGen - Boston
- Hazard
- Blood donor screening
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99922
- Recall number
- B-0256-2026
All recalls from CorneaGen - Boston
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA · Recall ended
In FDA's weekly enforcement report
Listed on Recall Canary
