CLASS II Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
Orca Foam Standard Cube 10x10x10 mm recalled by Gelita Medical
Gelita Medical is recalling Orca Foam Standard Cube 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, distributed nationwide in the US. The recall was initiated on 27 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1768-2022
- FDA event ID
- 90743
- Recalling firm
- Gelita Medical, Eberbach, N/A
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 Jul 2022
- FDA classified
- 19 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Jul 2022 | Recall initiated by company | |
| 19 Sep 2022 | Classified by FDA | +54 days |
| 28 Sep 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Product as listed by the FDA
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Where it was distributed
US Nationwide distribution in the state of Alabama.
Questions about this recall
Is Orca Foam Standard Cube 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP recalled?
Yes. Gelita Medical recalled Orca Foam Standard Cube 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP on 27 Jul 2022. The recall is Class II and its status is Completed. Recall number Z-1768-2022.
Why was it recalled?
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the state of Alabama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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