FDA Devices recall · Reported February 18, 2015
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).
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…
Stryker Instruments Div. of Stryker Corporation recalled Flyte Togas are components of the Stryker Flyte System and are intended to be worn over a… - a low-severity action.
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over a… was recalled by Stryker Instruments Div. of Stryker Corporation in February 18, 2015. Reason: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an inc…. Check the official notice for the remedy. Verify recall #Z-1077-2015 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this low-severity FDA Devices recall-A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an inc….
- Low
- severity level
- Class III
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1077-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1077-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on December 22, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 1530 units (170 cases).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1077-2015 |
| Date reported | February 18, 2015 |
| Date initiated | December 22, 2014 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 1530 units (170 cases) |
| Distribution | Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1077-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026