Severity
Moderate
FDA Devices recall · Reported November 27, 2013
It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who…
Stryker Medical Division of Stryker Corporation recalled Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intend… - a moderate-severity action.
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intend… was recalled by Stryker Medical Division of Stryker Corporation in November 27, 2013. Reason: It was reported that the siderail may appear latched when it is not, due to lack of proper preventive mainten…. Check the official notice for the remedy. Verify recall #Z-0363-2014 with the FDA Devices before acting.
The recall
Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-It was reported that the siderail may appear latched when it is not, due to lack of proper preventive mainten….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0363-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0363-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 23, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Medical Division of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 4126 units USA; 20449 inits Internationally.
The documented reason for this recall is: It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
4126 units USA; 20449 inits Internationally
Related Recalls
6
3 from same agency
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0363-2014 |
| Date reported | November 27, 2013 |
| Date initiated | October 23, 2013 |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 4126 units USA; 20449 inits Internationally |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 27, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.