Texas Medical Technology Inc.: Medical Device Recall in 2022 - (Recall #: Z-0242-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 1, 2022

Date Posted: November 23, 2022

Recall Number: Z-0242-2023

Event ID: 90833

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.

Status: Ongoing

Product Quantity: 100,000

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of FL.

Voluntary or Mandated:

Voluntary: Firm initiated