Agency classClass IIOur severity:High FDA (Devices)·Z-2205-2021·Announced 2021-08-18

Transport Stretcher 747 distributed to home users without professional training

Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.

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 an FDA Class II medical device recall with no reported illnesses or injuries. However, the device was designed exclusively for use by trained healthcare professionals in facilities but has been distributed to home users who may not understand safety-critical operational instructions, presenting a potential risk of patient injury from improper use. This risk-of-harm scenario without reported injuries corresponds to a High severity classification.

Plain-English summary

Stryker Medical Division is recalling the Transport Stretcher 747 (Part Number 0747000000), a non-powered, wheeled device designed to support patients in a horizontal position during transport.

The device is intended for use in healthcare facilities. However, units were distributed to residential customers in the United States and internationally, including Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. While the product labeling accurately identifies the correct use environment, home users may not be aware of or fully understand these instructions, which were designed for healthcare professionals. This mismatch between intended use and actual distribution creates a safety risk.

The recall addresses the risks associated with improper use by untrained home users who may lack the professional knowledge necessary to operate the device safely.

The recalled product

Product: Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Patient Transport Equipment
Hazard: improper-use
inadequate-training
intended-use-mismatch
Affected units: 3

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#): 07613327278187

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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