The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1863-2012·Announced 2012-07-04

Stryker Recalls Go Bed II+ Model FL 28 Ex Due to Scale Failures

Stryker is recalling 9,440 Go Bed II+ Model FL 28 Ex hospital beds due to an abnormally high failure rate of loadcells, which can cause scale errors or disabled functions.

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, disabled systems) without reporting any injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or functional defects without reported harm.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 9,440 units of the Go Bed II+ Model FL 28 Ex. These hospital beds are intended for medical purposes in general patient care and critical care environments. The beds feature built-in electric motors and controls that allow patients or caregivers to adjust the height and surface contour, and they include movable, 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 revealed an abnormally high failure rate of loadcells, which are integral components in the scale and bed exit functions. The scale faults are manifested as fluctuating scale readings, scale errors that cause the scale system to be disabled until serviced, or inaccurate readings.

The affected devices were distributed worldwide, including the United States (nationwide) and countries such as Argentina, Brazil, Canada, Chile, China, India, Mexico, Poland, Portugal, Puerto Rico, and Singapore. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact Stryker for further instructions on servicing or replacement.

The recalled product

Product
Go Bed II+ Model FL 28 Ex 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
9,440

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 FL28EX
  • Serial Numbers: QR09842
  • QM10376
  • QM10375
  • QM10374
  • QM10373
  • QM10372
  • QM10371
  • QM10370
  • QM10369
  • QM10368
  • QM10367
  • QM10366
  • QM10365
  • QM10364
  • QM10363
  • QM10362
  • QM10361
  • QM10360
  • QM10359

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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