Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

XGAUZE Trauma Dressing Recalled by Revmedx Inc Due to The XGAUZE Trauma Dressing was recalled because the...

Date: August 12, 2015
Company: Revmedx Inc
Status: Terminated
Source: FDA (Device)

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 Revmedx Inc directly.

Affected Products

XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

Quantity: 5004 units

Why Was This Recalled?

The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.

Where Was This Sold?

US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.

About Revmedx Inc

Revmedx Inc 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