Absorbable Gelatin Sponge Hemostat Recalled for Endotoxin Contamination
GELITA MEDICAL GMBH recalled 3,596 boxes of ORCA FOAM hemostats after routine testing found higher than acceptable endotoxin levels. The surgical devices were distributed across the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with detected endotoxin contamination, classified as a risk-of-harm product. No illnesses or injuries are reported in the source material, supporting Score 3 (High) per the severity rubric.
Plain-English summary
GELITA MEDICAL GMBH recalled ORCA FOAM STANDARD CUBE 10x10x10 mm absorbable gelatin sponge hemostats (UDI-DI 00860003109915) due to endotoxin contamination. The recall involves 3,596 boxes of 50 devices each. Affected batch numbers are T02371/1, T02371/2, T02395/1, and T02394/2, with expiration dates ranging from July to October 2026.
During routine bioburden testing, endotoxin levels higher than acceptable standards were detected. This finding prompted the manufacturer-initiated recall, which the FDA classified as Class II.
The affected products were distributed across the United States. ORCA FOAM is an absorbable gelatin sponge used in surgical procedures as a hemostat to control bleeding. Medical facilities and professionals should identify and isolate affected inventory using the batch numbers provided.
Facilities with affected products should contact GELITA MEDICAL GMBH for guidance on replacement or return of the recalled hemostats.
The recalled product
- Product
- ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
- Manufacturer
- GELITA MEDICAL GMBH
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI/DI 00860003109915
- Batch Numbers: T02371/1
- expiration date 10.02.2026
- T02371/2
- T02395/1
- expiration date 07.05.2026
- T02394/2
Distribution
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