XGAUZE Trauma Dressing — Class II medical device recall Z-2762-2015
Terminated recall by Revmedx Inc, reported 2015-09-23, distributed in AZ, ID, NC, TN, VA. The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shippi
| Recall number | Z-2762-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Revmedx Inc, Wilsonville, OR, United States |
| Recall initiated | 2015-08-12 |
| Classified | 2015-09-11 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-09-17 |
| Distributed | AZ, ID, NC, TN, VA |
| Quantity | 5,004 units |
| Reason classes | packaging |
| Lot numbers | ESO54391, ESO54725, ESO54726, ESO54741, ESO54742, ESO54743, ESO54744 |
| Model numbers | FIN-0002-01 |
| Expiration dates | 2020-03-18, 2020-03-30, 2020-04-06, 2020-04-13, 2020-04-16, 2020-04-23, 2020-09-25 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2762-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.