Z-0242-2023Class II

Disposable Surgical Level 3 Gown, Size/

Name: Z-0242-2023 Disposable Surgical Level 3 Gown, Size/
Creator: Texas Medical Technology Inc.
Published: 2022-09-01
License: https://open.fda.gov/license/

Texas Medical Technology Inc. / initiated 2022-09-01 / Open, Classified / root cause: manufacturing process

FDA source

Texas Medical Technology Inc. began a 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 on 2022-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0242-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-01
Posted: 2022-11-16
Recalling firm: Texas Medical Technology Inc.
Product: Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Product code: FYA Gown, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 100,000
Distribution: US Nationwide distribution in the state of FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0242-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0242-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-16

Product code FYA

K120192Class IIDisposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. / cleared 2012-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)