Stryker T4 Zipper Toga Sterile Garments Recalled for Layer Separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk of exposure to contaminants in a sterile medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling T4 Zipper Toga, Regular sterile personal protection garments (Catalog number: 0400-830-000). The recall involves 34,570 units distributed in the United States, Ireland, Japan, South Korea, and the UK. The affected lot numbers are 17113139 and 17113204.
The recall was initiated because separation of material layers may occur in these garments. This defect creates a potential risk of exposure to contaminants, which could compromise the sterile environment required for medical procedures.
Healthcare facilities and users should stop using the affected garments and contact Stryker for instructions on return or replacement. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- T4 Zipper Toga, Regular; Catalog number: 0400-830-000 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 (2)
- Lot numbers: 17113139
- 17113204
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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