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ModerateClass IITerminated

FDA Devices recall · Reported November 27, 2013

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…

Recall #
Z-0363-2014
Affected scope
4126 units USA; 20449 inits Internationally
Initiated
October 23, 2013
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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….

Moderate
severity level
4K units
affected scope
Class II
classification
November 27, 2013
reported

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.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

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

Reason for recall

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.

Recall Profile

Structured summary of the FDA Devices recall record
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.

Scale of Impact

4126 units USA; 20449 inits Internationally units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0363-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
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. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 4126 units USA; 20449 inits Internationally.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0363-2014.
Where was the recalled product distributed?
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported November 27, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026