Disposable Surgical Level 3 Gown, Size/Product Code:… recallZ-0242-2023 · Texas Medical Technology Inc. · initiated Sep 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Texas Medical Technology Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 9/1/22, a recall notice was sent to a distributor who was asked to forward the recall notice to their customers. Customers are asked to return the gowns to the distributor and to complete a self-address questionnaire to the recalling firm. The following contact information was provided: 346-250-2655, Monday through Friday 8 AM to 5 PM Central Time, [email protected] On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns.
Recall details
- Recall number
- Z-0242-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 1, 2022
- Posted by the FDA
- Nov 16, 2022
- Recalling firm
- Texas Medical Technology Inc.
- Quantity
- 100,000
- Product code
- FYA
- FDA submissions
- K120192
- Distribution
- US Nationwide distribution in the state of FL.
Product description
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Texas Medical Technology GWS-03-L-BTexas Medical Technology Inc · Gown, Surgical1 recall0 reports
- Texas Medical Technology GWS-03-XL-BTexas Medical Technology Inc · Gown, Surgical1 recall0 reports
- Texas Medical Technology GWS-03-XXL-BTexas Medical Technology Inc · Gown, Surgical1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page