The Recall Desk
HighFDA (Devices)·Z-0242-2023·Announced 2022-11-23

Surgical Level 3 Gowns Recalled for Inadequate Fluid Protection

Texas Medical Technology Inc. is recalling 100,000 Disposable Surgical Level 3 Gowns (sizes Large, XLarge, XXLarge) because the fabric fails to pass hydrostatic pressure tests, meaning blood and other body fluids may penetrate the gown.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving surgical gowns that fail to provide required fluid barrier protection. The hazard represents a significant risk-of-harm condition in a critical protective device, though no illnesses or injuries have been reported in the source.

Plain-English summary

Texas Medical Technology Inc. is recalling 100,000 Disposable Surgical Level 3 Gowns in sizes Large (Product Code GWS-03-L-B), XLarge (GWS-03-XL-B), and XXLarge (GWS-03-XXL-B). The affected lots are: GWS-03-L-B (lots 1300001, 1300002, 1300003, 1300004), GWS-03-XL-B (lots 1400001, 1400002, 1400003, 1400004), and GWS-03-XXL-B (lots 1500001, 1500002, 1500003, 1500004). These gowns were distributed nationwide with documented distribution in Florida.

The gowns are being recalled because the fabric fails to pass the hydrostatic pressure test required for Level 3 surgical gowns. When fabric fails this test, it cannot provide adequate protection against blood and other body fluids penetrating the material. This poses a risk to healthcare workers and patients who rely on these gowns for protection during surgical and other medical procedures.

If you have received these affected gowns, contact Texas Medical Technology Inc. or the FDA with information about affected inventory. Do not use the recalled gowns for any medical procedures.

The recalled product

Product
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Manufacturer
Texas Medical Technology Inc.
Category
Medical Device — Surgical Apparel
Hazard
  • barrier-failure
  • fluid-penetration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category