Stryker Flyte Toga Recall Due to Incorrect Expiration Date Labeling
Stryker is recalling Flyte Togas with an incorrect expiration date. The label reads 2412-12-01 instead of 2014-12-01.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a documentation/labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling a single lot of Flyte Toga Peel-away X-Large (catalog number 0408-830-100). The product is a component of the Stryker Flyte System intended to be worn over Stryker Flyte Helmets to provide liquid barrier protection.
The recall is due to a labeling error where the expiration date was printed as 2412-12-01. The correct expiration date for this lot is 2014-12-01. The affected lot number is 11121171.
A total of 1,530 units (170 cases) were distributed nationwide, including to Alabama, Arkansas, Arizona, Iowa, Illinois, Indiana, Louisiana, Massachusetts, North Carolina, Nebraska, New Mexico, South Carolina, Tennessee, Texas, Wisconsin, and West Virginia. Users should stop using the affected product and contact Stryker for instructions.
The recalled product
- 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Drapes
- Hazard
Distribution
Related recalls
Same manufacturer · Stryker Instruments Div. of Stryker Corporation
See all →- HighStryker Triton Canister Scanning Labels Recalled Due to Color Variance
FDA (Devices) · 2022-07-27
- ModerateTriton Sponge System Software Instructions Updated for Proper Sponge Handling
FDA (Devices) · 2022-07-27
- HighSurgiCount+ System software error bypasses sponge tracking alerts
FDA (Devices) · 2022-07-27
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- ModerateStryker Neptune E-SEP Blade Electrode Recalled for Expired Product
FDA (Devices) · 2020-05-06
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns
FDA (Devices) · 2013-06-12
- HighStryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach
FDA (Devices) · 2013-06-12
- HighStryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2013-06-12
- ModerateStryker Instruments Toga Sterile Barrier Recall
FDA (Devices) · 2013-06-12
- ModerateStryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
FDA (Devices) · 2013-06-12
- HighStryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2013-06-12