The Recall Desk
HighFDA (Devices)·Z-2220-2021·Announced 2021-08-18

Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

What this means for you

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 distributed to home users despite being designed for healthcare professionals. No injuries have been reported, but the distribution to an unsuitable environment creates a risk of harm from improper use by untrained individuals.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the stretcher chair Model 5050 (Part # 5050000000, UDI 07613327282511) due to distribution to residential customers.

The product is labeled for use in acute care hospitals and medical outpatient services. While the labeling correctly identifies the intended use environment, the devices were distributed to residential customers for home use. Home users may not be aware of or fully understand the instructions designed for healthcare professionals, creating a risk of improper use of equipment intended for trained medical staff.

The recalled product was distributed worldwide, including throughout the United States, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. If you have received this product, contact Stryker Medical Division for guidance on proper handling or return options.

The recalled product

Product
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • improper-use
  • unsuitable-environment

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)

  • Serial Numbers: N/A UDI: 07613327282511

Distribution

Distributed nationwide across the United States.