Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable… — Class II medical device recall Z-0363-2014
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2013-11-27, distributed nationwide. It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintena
| Recall number | Z-0363-2014 |
|---|---|
| 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 | 2013-10-23 |
| Classified | 2013-11-19 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, JP |
| Model numbers | B01008, B01010, B01022, B01045, B01323, B01356, B01392, B01433, B01434, B01465, B01466, B01467, B01470, B01542, B01597, B01598, B01602, B01729, B01779, B01780, B01781, B01995, B01996, B01997, B01998 and 475 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0363-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.