# FDA recall Z-1768-2022

> **GELITA MEDICAL GMBH** · Class II · device recall initiated 2022-07-27.

## Product

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

## Reason for recall

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

## Distribution

US Nationwide distribution in the state of Alabama.

## Key facts

- **Recall number:** Z-1768-2022
- **Recalling firm:** GELITA MEDICAL GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-07-27
- **Report date:** 2022-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eberbach, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2022

## Citation

> AI Analytics. FDA recall Z-1768-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1768-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*