FDA Device recall Z-1077-2015
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet
- FDA Device
- Class III
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class III recall of Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet by Stryker Instruments Div, citing A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date shou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1077-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-12-22 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
Reason
A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.
Identifiers
| code_info | Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01 |
|---|
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-1077-2015%22
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