Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
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 theoretical potential breach in the sterile barrier identified through accelerated aging tests, with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 3,000 units (300 boxes) of Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O. These single-use surgical drapes are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids. The affected units were distributed nationwide in the United States.
The recall was initiated following an accelerated aging test of the product packaging. The testing, which used high heat to simulate aging, indicated a potential for a breach in the sterile barrier of 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. Stryker is currently conducting additional testing and assessing the product.
Healthcare facilities and consumers should stop using the affected T4 Toga surgical drapes immediately. Users should check their inventory for the specific product code 0400-820-000S3 and the associated lot codes 1007145, 1101004, or 1107487. Affected units should be returned to Stryker Instruments for further evaluation.
The recalled product
- Product
- Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; 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
- 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 (3)
- 1007145
- 1101004
- 1107487
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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