Stryker T5 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential exposure to infectious agents.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 25,770 units (2,577 boxes) of Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, 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 for the product packaging. The test, which used high heat to simulate aging, 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.
Healthcare facilities and consumers should stop using the affected T5 Zipper Toga products and contact Stryker for further instructions or a return. The specific lot codes associated with this recall include 1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 1109786, 1006141, 1012303, 1102110, 1104324, and 1108664.
The recalled product
- Product
- Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, 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 (20)
- 1006130
- 1101034
- 1006134
- 1102133
- 1007151
- 1103208
- 1007170
- 1104297
- 1009205
- 1105360
- 1010228
- 1106476
- 1010260
- 1107569
- 1011296
- 1108676
- 1012336
- 11097861006141
- 1012303
- 1102110
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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