# FDA recall Z-0242-2023

> **Texas Medical Technology Inc.** · Class II · device recall initiated 2022-09-01.

## 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.

## Distribution

US Nationwide distribution in the state of FL.

## Key facts

- **Recall number:** Z-0242-2023
- **Recalling firm:** Texas Medical Technology Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-01
- **Report date:** 2022-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2023

## Citation

> AI Analytics. FDA recall Z-0242-2023. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0242-2023. Source: US FDA. Licensed CC0.

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