Disposable Surgical Level 3 Gown — Class II medical device recall Z-0242-2023
Ongoing recall by Texas Medical Technology Inc., reported 2022-11-23, distributed nationwide. Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does no
| Recall number | Z-0242-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Texas Medical Technology Inc., Sugar Land, TX, United States |
| Recall initiated | 2022-09-01 |
| Classified | 2022-11-16 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 100,000 |
| UPC / GTIN / UDI-DI | 00850022960338, 00850022960345, 00850022960352 |
| Lot numbers | 1300002, 1300003, 1300004, 1400002, 1400003, 1400004, 1500002, 1500003, 1500004 |
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 for recall
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.
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-0242-2023. 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.