ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin… recallZ-1768-2022 · Gelita Medical GMBH · initiated Jul 27, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gelita Medical GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1768-2022
- Status
- Terminated
- Initiated by the company
- Jul 27, 2022
- Recalling firm
- Gelita Medical GMBH
- Quantity
- 3596 boxes of 50 devices
- Product code
- LYA
- FDA submissions
- K060878
- Distribution
- US Nationwide distribution in the state of Alabama.
Product description
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ORCA Foam StandardOrca Products, LLC · Splint, Intranasal Septal1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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