GELITA recalls ORCA Foam Standard Cube hemostats with endotoxin levels above acceptable limits in bioburden testing. Affected units have specific batch numbers and expiration dates. Consumers should check their product details.
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
GELITA Medical GmbH is recalling ORCA Foam Standard Cube hemostats due to higher than acceptable endotoxin levels found in routine bioburden testing. This could pose a risk of infection or other complications during medical procedures if used improperly.
Endotoxins are bacterial components that can cause infections or adverse reactions when introduced into the body. Higher than acceptable levels in these hemostats could lead to complications during medical procedures if the product is used improperly.
Medical professionals and patients using the ORCA Foam Standard Cube hemostats for procedures. Those with the specific batch numbers listed in the recall are most at risk.
Check for the batch numbers T02371/1, T02371/2, T02395/1, or T02394/2 on the product label. The expiration dates for these batches are 10.02.2026 or 07.05.2026.
Look for the batch numbers T02371/1, T02371/2, T02395/1, or T02394/2 on the product label.
Routine bioburden testing found higher than acceptable levels of endotoxins in these products.
Check for the batch numbers T02371/1, T02371/2, T02395/1, or T02394/2 on the product label.
The recall does not specify a remedy, so contact GELITA Medical GmbH for further instructions.
We’ve drafted a message you can send GELITA to request your refund or repair — edit it as you like.
Subject: Recall Z-1768-2022 — GELITA GELITA Hello, I own a GELITA that is covered by recall Z-1768-2022 from GELITA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
