Agency classClass IIOur severity:High FDA (Devices)·Z-2208-2021·Announced 2021-08-18

Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance

The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.

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: FDA Class II classification indicates moderate risk. The device is designed for professional healthcare use only but was distributed to home users who may not understand professional-only instructions. This creates risk of improper use and potential injury in an unsupervised home setting, though no illnesses or injuries have been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation identified an issue with the Prime Big Wheel Stretcher (Model 1115, Part Number 1115000030). The device is intended for use in healthcare facilities for short-term clinical evaluation, treatment, minor procedures, and recovery. Its labeling correctly identifies these professional-only requirements.

However, the stretcher was distributed worldwide, including to residential customers in the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Home users may not be aware of or fully understand that this device requires professional healthcare facility use, as the instructions are written for trained healthcare professionals.

Consumers with this device should review the labeling to confirm they understand its professional-only use requirements. The product is not designed for unsupervised use in home environments.

The recalled product

Product: Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Patient Transport Equipment
Hazard: improper-use
fall-injury
insufficient-training
Affected units: 1

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)

UDI (DI#): 07613327278330

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Stryker Medical Division of 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 19 products in this recall →

Same manufacturer · Stryker Medical Division of Stryker Corporation

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