The Recall Desk
HighFDA (Devices)·Z-1861-2012·Announced 2012-07-04

Stryker Rose Bed Recall Due to Loadcell Failure in Scale Function

Stryker is recalling Rose Model FL14E beds because loadcell failures cause scale errors and disabled bed exit functions.

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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical bed with safety features) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling Stryker Rose Bed Model FL14E units. These beds are intended for medical purposes in general patient care and critical care environments, featuring built-in electric motors and controls for adjusting height and surface contour. The devices include movable and latchable side rails to help prevent patient falls.

The recall was initiated after an adverse trend of service reports and complaints was detected for the GoBed+, GoBed II, Rose, and MA204 model beds. An investigation found an abnormally high failure rate of loadcells, which are integral components in the scale and bed exit functions. These scale faults manifest as fluctuating scale readings, scale errors that disable the scale system until serviced, or inaccurate readings.

Approximately 999 units are affected by this recall. The devices were distributed worldwide, including the USA (nationwide) and countries such as Argentina, Brazil, Canada, Chile, China, India, Mexico, and Singapore. Consumers and healthcare facilities should check their serial numbers against the provided list and contact Stryker for further instructions.

The recalled product

Product
Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface co
Affected units
999

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 (20)

  • Model FL14E: Serial Number QB22371
  • QB22370
  • QB22369
  • QB22368
  • QB22367
  • QB21200
  • QB18330
  • QB17733
  • B22524
  • B22523
  • B22522
  • B22521
  • B22506
  • B22505
  • B22504
  • B22503
  • B22502
  • B22501
  • B22500
  • B22446

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →