The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1862-2012·Announced 2012-07-04

Stryker MA204 Bed Recall Due to Loadcell Failure in Scale Function

Stryker is recalling MA204 beds because loadcells in the scale and bed exit systems are failing at an abnormally high rate.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes functional failures (fluctuating readings, system disabling) without reporting any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall involving low-risk contamination or functional defects without reported harm.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 2,546 Stryker MA204 Bed Model (FL25E) 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 recall was initiated after an adverse trend of scale and bed exit service reports and complaints was detected for the MA204 model beds, among others. 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.

The affected devices were distributed worldwide, including in the United States (nationwide) and countries such as Argentina, Brazil, Canada, Chile, China, India, Mexico, and Singapore. Healthcare facilities and consumers should contact Stryker for further instructions on servicing or replacing the affected loadcells.

The recalled product

Product
Stryker MA204 Bed Model (FL25E) 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…
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Bed
Hazard
Affected units
2,546

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 FL25E: QK02276
  • QK02274
  • QK01602
  • KK01602
  • K03922
  • K03921
  • K03920
  • K03919
  • K03918
  • K03917
  • K03916
  • K03915
  • K03914
  • K03913
  • K03912
  • K03911
  • K03910
  • K03909
  • K03908
  • K03907

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 →

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