Stryker Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 6,990 units (699 boxes) of Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO. These single-use products are intended to protect patients, healthcare personnel, and operating room personnel against contamination and exposure to infectious bodily fluids. The affected units were distributed nationwide in the United States.
The recall was initiated based on an accelerated aging test for the product packaging. The test, which used high heat to accelerate the aging of the packaging, 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. Stryker is conducting additional testing and assessing the product.
The affected product codes are 1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634. Healthcare facilities and consumers should check their inventory for these specific codes and stop using the product if it matches the recalled description.
The recalled product
- Product
- Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, 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,
- 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 (7)
- 1006124
- 1007164
- 1010236
- 1011296
- 1103168
- 1105341
- and 1108634.
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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