FDA Device recall Z-1809-2012
T5 Hytrel Zipper Toga
- FDA Device
- Class II
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class II recall of T5 Hytrel Zipper Toga by Stryker Instruments Div, citing the clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1809-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-01 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Reason
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Identifiers
| code_info | Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2012%22
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