FDA Device recall Z-1768-2022
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- FDA Device
- Class II
- completed
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM by Gelita Medical, citing in routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1768-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-07-27 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gelita Medical |
| Distribution | US |
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Reason
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Identifiers
| code_info | UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T023…UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1768-2022%22
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