Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach
Stryker is recalling 3,000 units of T4 Toga surgical gowns 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, but the source text describes a 'potential' breach based on accelerated testing without reporting any actual illnesses, injuries, or hospitalizations. This aligns with the rubric for voluntary precautionary recalls or low-risk contamination where harm has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 3,000 units (300 boxes) of Stryker Instruments 0400-750-000 T4 Toga, Pullover, Regular Sterile, EO surgical gowns. These single-use products are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids.
The recall was initiated following an accelerated aging test of the product packaging. The testing, which used high heat to accelerate the aging process, indicated a potential for a breach in the sterile barrier within 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.
The affected units were distributed nationwide in the USA. The specific lot codes associated with this recall are 1005111, 1011282, 1107491, and 1107492. Healthcare facilities and consumers should check their inventory for these specific lot codes and stop using the affected products if found.
The recalled product
- Product
- Stryker Instruments0400-750-000 T4 Toga, Pullover, 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 t
- 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 (4)
- 1005111
- 1011282
- 1107491
- 1107492
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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