The Recall Desk
HighFDA (Devices)·Z-2211-2021·Announced 2021-08-18

Stryker Proform pressure ulcer support surface distributed to home users

Stryker Proform pressure ulcer support surfaces designed for healthcare facility use were distributed to residential customers. The device labeling is correct but home users may not understand professional-level instructions.

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 an FDA Class II recall involving a risk-of-harm medical device designed for healthcare professionals being distributed to untrained home users. No illnesses or injuries have been reported, but the potential for harm is significant due to the instruction-comprehension gap and use-environment mismatch. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the Proform support surface (Model 2710, Serial Number 111427102713678) due to inappropriate distribution. This device is intended for use in healthcare facilities to assist in the prevention and treatment of pressure ulcers of all categories and stages. However, the device was distributed to residential customers for home use.

The device's labeling accurately identifies its intended use environment as a healthcare facility setting. Medical professionals in healthcare settings are trained to properly use and manage this equipment. Home users, however, may not be aware of or fully understand these professional-level instructions, creating a risk of inappropriate use.

The product has been distributed worldwide, including to the United States and internationally to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Consumers who have received this device should contact Stryker Medical or their healthcare provider for guidance on appropriate use or removal of the device from the home environment.

The recalled product

Product
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Pressure ulcer prevention and treatment
Hazard
  • inappropriate-use
  • instruction-comprehension
  • use-environment-mismatch

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: 111427102713678 UDI:N/A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category