Stryker Instruments Toga Sterile Barrier Recall
Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during 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, and the hazard is a potential sterile barrier breach identified through testing without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 3,980 units (398 boxes) of Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O. These single-use products 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 was identified within the second and third year of the product's shelf life. Stryker is conducting additional testing and assessing the product.
The affected products were distributed nationwide in the USA. Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed in the recall notice.
The recalled product
- Product
- Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, 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, and the
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Drapes
- Hazard
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 (4)
- 1005098
- 1010228
- 1012337
- 1105367
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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