The Recall Desk
HighFDA (Devices)·Z-2222-2021·Announced 2021-08-18

Stryker Electric Hospital Beds Recalled for Unintended Home Use

Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.

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: Class II medical device recall for a product being used in unintended home environments by users who may not understand professional-level instructions. No illnesses or injuries have been reported, but there is a risk-of-harm potential from improper use.

Plain-English summary

Stryker Medical Division of Stryker Corporation has recalled the Electric MedSurg Bed FL23, an electrically powered adjustable hospital bed with four built-in DC motors and remote controls. Nine units are affected.

These beds were designed and intended for use in healthcare facilities by trained professionals. However, they were distributed to and are currently in use in residential home environments. While the product's labeling correctly identifies the intended use in healthcare settings, home users may not be aware of or fully understand the instructions, which were designed specifically for healthcare professionals.

The recalled units have been distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.

The recalled product

Product
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • improper-use
  • inadequate-instructions

Distribution

Distributed nationwide across the United States.