Z-1768-2022Class II

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

Name: Z-1768-2022 ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Creator: Gelita Medical Gmbh
Published: 2022-07-27
License: https://open.fda.gov/license/

Gelita Medical GmbH / initiated 2022-07-27 / Completed / root cause: sterility

FDA source

GELITA MEDICAL GMBH began a recall of ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM on 2022-07-27. FDA classified it as Class II and gives the reason as "In routine bioburden testing, higher than acceptable levels of Endotoxins were observed". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1768-2022
Classification: Class II
Status: Completed
Initiated: 2022-07-27
Posted: 2022-09-19
Recalling firm: Gelita Medical GmbH
Product: ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Product code: LYA Splint, Intranasal Septal
Reason for recall: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Root cause tag: sterility
FDA 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 in commerce: 3596 boxes of 50 devices
Distribution: US Nationwide distribution in the state of Alabama.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1768-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1768-2022	Class II	Completed	Voluntary: Firm initiated	2022-09-28	2022-09-19

Product code LYA

K060878Class IIGelita-Spon Absorbable Gelatin Sponge, UspCuramedical, BV / cleared 2006-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)