ORCA FOAM STANDARD CUBE 10x10x10 mm — Class II medical device recall Z-1768-2022
Completed recall by GELITA MEDICAL GMBH, reported 2022-09-28, distributed nationwide. In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
| Recall number | Z-1768-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | GELITA MEDICAL GMBH, Eberbach, N/A, Germany |
| Recall initiated | 2022-07-27 |
| Classified | 2022-09-19 |
| Reported by FDA | 2022-09-28 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00860003109915 |
| Lot numbers | T02371/1, T02371/2, T02394/2, T02395/1 |
| Expiration dates | 2026-07-05, 2026-10-02 |
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Reason for recall
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1768-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.