FDA Device recall Z-2425-2012
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File
- FDA Device
- Class III
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class III recall of ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File by Kimberly Clark, citing the impacted product was not intended for commercial distribution to end users.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2425-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2010-12-31 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kimberly Clark |
| Distribution | US |
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
The impacted product was not intended for commercial distribution to end users.
Identifiers
| code_info | Product Code: 95221-35, Unit Code: 90372 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.