GELITA MEDICAL GMBH Uferstr. 7 Eberbach Germany ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Brand
GELITA MEDICAL GMBH Uferstr. 7 Eberbach Germany
Lot Codes / Batch Numbers
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
Products Sold
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
GELITA MEDICAL GMBH Uferstr. 7 Eberbach Germany is recalling ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM due to In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Recommended Action
Per FDA guidance
The firm emailed a Field Safety Notice to the sole consignee, a distributor, on 07/27/2022, 08/11/2022 and 08/15/2022. The first letter explained the problem, hazard, and requested the return of the product. If the product was further distributed to notify customers. The second and third letters requested that the recalled articles be destroyed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026