ULTRA Fabric Reinforced Surgical Gown — Class III medical device recall Z-2425-2012
Terminated recall by Kimberly-Clark Corporation, reported 2012-09-26, distributed nationwide. The impacted product was not intended for commercial distribution to end users.
| Recall number | Z-2425-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kimberly-Clark Corporation, Roswell, GA, United States |
| Recall initiated | 2010-12-31 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2012-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 32 cases |
Product
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Reason for recall
The impacted product was not intended for commercial distribution to end users.
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-2425-2012. 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.