Drug recall
Cornea
FDA recall event 99913 · Class II · CorneaGen - Boston
Key facts
| Event ID | 99913 |
|---|---|
| Recall numbers | B-0248-2026 |
| Recalling firm | CorneaGen - Boston |
| Product type | Biologics |
| Products | Cornea |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed. |
| Initiation date | Jul 18, 2024 |
| Report date | Sep 30, 2026 |
| Termination date | Sep 25, 2026 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 1000513310 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: