T4-Hytrel Zipper Toga Product Usage — Class II medical device recall Z-1810-2012
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2012-06-20, distributed nationwide. The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surg
| Recall number | Z-1810-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2012-06-01 |
| Classified | 2012-06-14 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2014-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Lot numbers | T4-HYTREL |
| Model numbers | 0400-821-000, 0400-841-000, 0400-851-000 |
Product
T4-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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1810-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.