CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
Disposable Surgical Level 3 Gown, Size/Product recalled
Texas Medical Technology is recalling Disposable Surgical Level 3 Gown, Size/Product, distributed nationwide in the US. The recall was initiated on 1 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0242-2023
- FDA event ID
- 90833
- Recalling firm
- Texas Medical Technology, Sugar Land, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Sep 2022
- FDA classified
- 16 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 1 Sep 2022 | Recall initiated by company | |
| 16 Nov 2022 | Classified by FDA | +76 days |
| 23 Nov 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Where it was distributed
US Nationwide distribution in the state of FL.
Questions about this recall
Is Disposable Surgical Level 3 Gown, Size/Product recalled?
Yes. Texas Medical Technology recalled Disposable Surgical Level 3 Gown, Size/Product on 1 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0242-2023.
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the state of FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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