Texas Medical Technology Inc. Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Brand
Texas Medical Technology Inc.
Lot Codes / Batch 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
Products Sold
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
Texas Medical Technology Inc. is recalling Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/G due to 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 lev. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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, sales@texasmedicaltechnology.com On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026