Z-1077-2015Class III

Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte...

Name: Z-1077-2015 Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2014-12-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-12-22 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2014-12-22. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1077-2015
Classification: Class III
Status: Terminated
Initiated: 2014-12-22
Posted: 2015-02-10
Terminated: 2015-05-05
Recalling firm: Stryker Corp.
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).
Product code: FYA Gown, Surgical
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Stryker sent an Urgent Medical Device Recall Notification letter dated December 22, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and responding to the formal recall notification. Customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in their inventory. Complete and return the BRF even if they do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If customers further distributed this product, they were instructed to forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Completed Business Reply Forms should be faxed to 866-521-2762. Upon receipt of the Business Reply Form, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Flyte Toga(s) to Stryker. Upon receipt of the recalled Flyte Toga(s), credit will be applied to the customer's account. For questions regarding this recall customers were instructed to contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2458. For questions regarding this recall call 269-389-2458.
Quantity in commerce: 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.
Product codes and lots: Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2015	Class III	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code FYA

K073017Class IIStryker Stri-Shield Flyte TogasStryker Instruments, Instruments Div. / cleared 2007-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)