Agency classClass IIOur severity:High FDA (Devices)·Z-2259-2024·Announced 2024-07-10

Stryker Flyte Hood Protective Covers Recalled Due to Expired Products

Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—expired equipment that may not function as intended constitutes a risk-of-harm product where injury has not yet been reported, justifying a score of 3 (High).

Plain-English summary

Stryker Corporation is recalling Non-Sterile Flyte hood protective covers with Lot Number 20040649. The hood is designed to cover the head and neck region and is worn with the Flyte helmet and commercial gowns as part of a protective system for healthcare workers.

The recalled units were distributed to customers with expired product status. Expired medical devices may not meet performance standards or function as intended, creating uncertainty regarding their effectiveness and safety.

Affected units were distributed nationwide in the states of Arkansas, California, Colorado, Florida, and Michigan. The recall affects 4 units with GTIN 07613327514063.

Customers who have received these units should contact Stryker Corporation to confirm whether they have received affected product and to arrange for replacement units. Do not use expired protective equipment.

The recalled product

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…
Manufacturer: Stryker Corporation
Category: Medical Device — Protective Equipment
Hazard: device-malfunction
expiration-date
Affected units: 4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

GTIN: 07613327514063 Lot Number: 20040649

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Stryker Corporation

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