Z-2259-2024Class II

The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with...

Name: Z-2259-2024 The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with...
Creator: Stryker Corporation
Published: 2024-06-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-06-03 / Open, Classified

FDA source

Stryker Corporation began a recall of 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... on 2024-06-03. FDA classified it as Class II and gives the reason as "Expired Products distributed to customers". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2259-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-03
Recalling firm: Stryker Corp.
Product: 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
Product code: OEA Non-Surgical Gown
Reason for recall: Expired Products distributed to customers
FDA root cause: Storage
Action: Stryker issued Urgent Medical Device Recall Letter on 6/3/24 via Fed'X. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to [email protected], even if affected product is no longer in your inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will arrange for replacement product(s) to be shipped promptly. 4. Maintain awareness of this communication internally and inform Stryker if any of the devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Lacey Marshall at 269-270-5950 or [email protected] with questions or concerns.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Product codes and lots: GTIN: 07613327514063 Lot Number: 20040649

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2259-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2259-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2260-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2261-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code OEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)