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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Surgical Level 3 Gown

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  Class 2 Device Recall Disposable Surgical Level 3 Gown see related information
Date Initiated by Firm September 01, 2022
Date Posted November 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0242-2023
Recall Event ID 90833
510(K)Number K120192  
Product Classification Gown, surgical - Product Code FYA
Product 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 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
Recalling Firm/
Texas Medical Technology Inc.
1111 Gillingham Ln
Sugar Land TX 77478-2865
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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, sales@texasmedicaltechnology.com 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD