Stryker MA204 Bed Model — Class II medical device recall Z-1862-2012
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2012-07-04, distributed nationwide. An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose
| Recall number | Z-1862-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2012-05-17 |
| Classified | 2012-06-22 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2014-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CN, IN, MX, PT, SG |
| Quantity | 2,546 |
| Model numbers | FL20E, FL25E, FL28C, FL28EX, K00000, K00004, K00005, K00029, K00030, K00031, K00032, K00033, K00034, K00035, K00036, K00037, K00038, K00039, K00040, K00041, K00042, K00043, K00044, K00045, K00046 and 475 more |
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 contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
Reason for recall
An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.