Eberbach, N/A, Germany
GELITA MEDICAL GMBH recalls
1 recall recorded since 2018, most recently on 27 July 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 27 July 2022
- Terminated
- 22 September 2026
- Reason
- In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
- Distribution
- US Nationwide distribution in the state of Alabama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1768-2022
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.