Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is based on a potential breach identified in testing without reported illnesses or injuries, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 5,000 units (500 boxes) of Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO products. These single-use protection systems are intended to protect patients, healthcare personnel, and operating room personnel against contamination and exposure to infectious bodily fluids.
The recall was initiated following an accelerated aging test for the product packaging. The test indicated a potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing the product.
The affected products were distributed nationwide in the USA. The specific lot codes involved are 1006141, 1012303, 1102110, 1104324, and 1108664. Healthcare facilities should check their inventory for these specific codes and stop using the affected products.
The recalled product
- Product
- Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
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 (5)
- 1006141
- 1012303
- 1102110
- 1104324
- and 1108664
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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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