FDA Medical Device Recalls (openFDA)
GELITA MEDICAL GMBH: ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Recall number
- Z-1768-2022
- Recalling firm
- GELITA MEDICAL GMBH
- Product
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Status
- Completed
- Initiated
- 2022-07-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 3596 boxes of 50 devices
- Distribution
- US Nationwide distribution in the state of Alabama.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K060878
- PMA numbers
- not on file
- Product code
- LYA
- Firm FEI
- 3010208179
- Firm city
- Eberbach
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28