FDA recall, , Moderate risk
CorneaGen Cornea
Corneas were distributed without adequate donor eligibility determination.
Recall ended Sep 25, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
CorneaGen - Boston is recalling corneas because donor eligibility was not adequately determined before the corneas were distributed. The recall began on July 18, 2024, and the FDA added the recall to its Enforcement Report on September 21, 2026. The corneas were distributed in Massachusetts and Maryland.
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
- Sold in
- 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
- 99913
- Recall number
- B-0248-2026
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
