Stryker Recalls GoBed+ Model FL20E Hospital Beds Due to Scale Failures
Stryker is recalling 6,325 GoBed+ Model FL20E hospital beds worldwide because loadcell failures can cause scale errors or disable bed exit 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 3/5 (High).
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 defect involves a safety feature (bed exit/side rails) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 6,325 units of the GoBed+ Model FL20E hospital bed. These devices are intended for medical purposes in general patient care and critical care environments, featuring built-in electric motors to adjust height and surface contour, as well as movable side rails to help prevent patient falls.
The recall was initiated after an investigation detected an abnormally high failure rate of loadcells, which are integral components for the scale and bed exit functions. This defect can manifest as fluctuating scale readings, scale errors that disable the system until serviced, or inaccuracy in the scale function. The affected units were distributed worldwide, including in the United States, Argentina, Brazil, Canada, Chile, China, India, Mexico, Poland, Portugal, Puerto Rico, and Singapore.
Healthcare facilities should stop using the affected beds and contact Stryker for instructions on how to resolve the issue. The recall number is Z-1859-2012.
The recalled product
- Product
- GoBed+ . Model FL20E 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…
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
- Affected units
- 6,325
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 FL20E: Serial
- Number
- Listing
- for
- Model
- FL20E QG06844
- QG06842
- G08119
- G08118
- G08117
- G08116
- G08115
- G08114
- G08113
- G08112
- G08111
- G08110
- G08109
- G08108
- G08107
Distribution
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.
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