GELITA MEDICAL GMBH: ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

Is my product affected?

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

• UPC 00860003109915

Check against the official notice below — it lists the full affected range.

What happened

Gelita Medical GmbH has recalled ORCA FOAM Standard Cube absorbable gelatin sponge hemostats (medical devices used to control bleeding) due to higher than acceptable levels of endotoxins detected during routine bioburden testing. The recall affects 3,596 boxes containing 50 devices each, distributed nationwide in Alabama, with four affected batch numbers and expiration dates ranging from July 5, 2026 to October 2, 2026.

The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Details from the source

Reason for recall: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. Distribution: US Nationwide distribution in the state of Alabama. Quantity: 3596 boxes of 50 devices Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. 2022-07-27
• Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD2022-07-26
• Nobel Biocare N1 TiUltra TCC NP 3.5x13mm2022-07-25
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H9386900252022-07-22
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H9386731002022-07-22

All FDA (Device enforcement) recalls