Stryker Recalls T4 Pullover Toga Due to Material Separation Risk
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (exposure to contaminants) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling T4 Pullover Toga, X-Large sterile personal protection garments (Catalog Number: 0400-770-000). The recall involves 34,570 units distributed in the United States, Ireland, Japan, South Korea, and the United Kingdom.
The recall was initiated because separation of material layers may occur, which causes a potential risk of exposure to contaminants. This defect compromises the integrity of the sterile barrier intended to protect patients and healthcare workers.
Affected lot numbers include 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, and 17113190. Healthcare facilities and consumers should stop using these garments and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
- Affected units
- 34,570
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 (11)
- Lot numbers: 17061775
- 17061781
- 17061784
- 17061793
- 17102891
- 17102916
- 17102925
- 17102995
- 17113013
- 17113083
- 17113190
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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