Stryker T4 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a 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 source describes a risk-of-harm product (sterile barrier failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling T4 Zipper Toga sterile personal protection garments, size L/XL, catalog number 0400-820-000. The recall involves 34,570 units distributed nationwide in the United States and in Ireland, Japan, South Korea, and the United Kingdom.
The recall was initiated because separation of material layers may occur in the garments. This defect creates a potential risk of exposure to contaminants, which could compromise the sterile barrier intended for patient protection during surgical procedures.
The affected lot numbers are: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, and 17113221. Healthcare facilities should stop using these specific lots and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- 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 (20)
- Lot numbers: 17061810
- 17061814
- 17071878
- 17071903
- 17071918
- 17071920
- 17071949
- 17071960
- 17071970
- 17071974
- 17071997
- 17072002
- 17072006
- 17072016
- 17102897
- 17102926
- 17102936
- 17102942
- 17102956
- 17102971
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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