GELITA MEDICAL GMBH: Medical Device Recall in 2022 - (Recall #: Z-1768-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 27, 2022

Date Posted: September 28, 2022

Recall Number: Z-1768-2022

Event ID: 90743

Reason for Recall:

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Status: Completed

Product Quantity: 3596 boxes of 50 devices

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of Alabama.

Voluntary or Mandated:

Voluntary: Firm initiated