Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 10, 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/function
Expired Products distributed to customers
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Corporation recalled The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be w… - a moderate-severity action.
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be w… was recalled by Stryker Corporation in July 10, 2024. Reason: Expired Products distributed to customers. Check the official notice for the remedy. Verify recall #Z-2259-2024 with the FDA Devices before acting.
The recall
Stryker Corporation issued this moderate-severity FDA Devices recall-Expired Products distributed to customers.
- Moderate
- severity level
- 4 units
- affected scope
- Class II
- classification
- July 10, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2259-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2259-2024) was formally reported on July 10, 2024, with the manufacturer initiating the action on June 3, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 4 units.
The documented reason for this recall is: Expired Products distributed to customers Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4 units
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
Expired Products distributed to customers
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2259-2024 |
| Date reported | July 10, 2024 |
| Date initiated | June 3, 2024 |
| Recalling firm | Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 4 units |
| Distribution | US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan. |
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-2259-2024) 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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Corporation. Units affected: 4 units.
Why was this product recalled? ▼
Expired Products distributed to customers
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2259-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2259-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.