Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ORCA FOAM STANDARD CUBE 10x10x10 mm Recalled by GELITA MEDICAL GMBH Due to In routine bioburden testing, higher than acceptable levels...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GELITA MEDICAL GMBH directly.
Affected Products
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Quantity: 3596 boxes of 50 devices
Why Was This Recalled?
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GELITA MEDICAL GMBH
GELITA MEDICAL GMBH has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report