FDA Device recall Z-0242-2023
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B by Texas Medical Technology, citing surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0242-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-01 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Texas Medical Technology |
| Distribution | US |
Product
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Reason
Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.
Identifiers
| code_info | Product Code/UDI-DI/Lots: GWS-03-L-B/00850022960338/1300001, 1300002, 1300003, 1300004; GWS-03-XL-B/00850022960345/1400…Product Code/UDI-DI/Lots: GWS-03-L-B/00850022960338/1300001, 1300002, 1300003, 1300004; GWS-03-XL-B/00850022960345/1400001, 1400002, 1400003, 1400004; GWS-03-XXL-B/00850022960352/1500001, 1500002, 1500003, 1500004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0242-2023%22
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