Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate 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, 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 48,040 units (4804 boxes) of T4 Pullover Toga (L/XL) Sterile, EO single-use products. These products are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids. The units were distributed nationwide in the United States.
The recall is based on 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 recalled product
- Product
- Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) 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 the
- 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 (20)
- 1005105
- 1010244
- 1101004
- 1104289
- 1107568
- 1005119
- 1010261
- 1101030
- 1104324
- 1108625
- 1006129
- 1011276
- 1101047
- 1105390
- 1108672
- 1006140
- 1011296
- 1102073
- 1105355
- 1109730
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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