Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling 2,000 units of T4 Toga surgical drapes 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 a potential sterile barrier breach identified in testing without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 2,000 units (200 boxes) of Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO. These single-use surgical drapes are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids.
The recall is based on accelerated aging tests for the product packaging, which indicated a potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap. This potential breach could occur within the second and third year of the product's shelf life. The test method used involved high heat to accelerate the aging of the packaging.
The affected products were distributed nationwide in the USA. Stryker is conducting additional testing and assessing the product. Healthcare facilities should stop using the affected units and contact Stryker for further instructions.
The recalled product
- Product
- Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Drapes
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)
- 1010236
- 1108682
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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