ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is… — Class II medical device recall Z-0257-2013
Terminated recall by Kimberly-Clark Corporation, reported 2012-11-14, distributed nationwide. Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as label
| Recall number | Z-0257-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kimberly-Clark Corporation, Roswell, GA, United States |
| Recall initiated | 2012-07-05 |
| Classified | 2012-11-07 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-06-13 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, sterility |
Product
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product 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
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
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-0257-2013. 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.