“Stry: Non-Sterile Flyte Hood Recall for Expired Products.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54938-stry-non-sterile-flyte-hood-recall-for-expired-products. Based on FDA recall #Z-2259-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2259-2024%22&limit=1).
The FDA announced on June 3, 2024, that Stryker Corporation is recalling The Non-Sterile Flyte hood covers due to expired products being distributed to customers. This voluntary Class II recall affects units distributed nationwide in Arkansas, California, Colorado, Florida, and Michigan.
How to tell if you have it
Brand: Stryker
Product: The Non-Sterile Flyte hood
Catalog Number: 0408-800-000NS
GTIN/UPC: 07613327514063
Lot Number: 20040649
The hazard
The recall involves expired products distributed to customers. The Non-Sterile Flyte hood covers the user's head and neck region and is intended to be worn with commercially available gowns.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include a June 8, 2026 recall for irrigator handpieces leaking during use and a May 6, 2026 recall for Neptune Smart Docking Stations with electrical shock risks. Other recent recalls of similar products include the April 10, 2026 Stryker BARD Dynamic Tip Steerable recall for incomplete sterile seals risk and the April 10, 2026 Stryker BW Webster Duo-Decapolar Catheter recall for incomplete sterile seals.
How to tell if you have this one
Check for the catalog number 0408-800-000NS and lot number 20040649 on the hood. The product was distributed to customers with these specific identifiers.
Brand
Stryker
Product
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Recall number
Product, codes & lots
Quantity
Z-2259-2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS; GTIN: 07613327514063 Lot Number: 20040649
4 units
Z-2260-2024
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500; GTIN: 07613327374629 Lot Number: 6659783
3 units
Z-2261-2024
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225; GTIN: 07613327118438 Lot Number: 1000388946
8 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog number 0408-800-000NS and lot number 20040649 on the hood.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Colorado, Florida, Michigan.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2259-2024 (June 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2259-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.