Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical…
Medical device recall Z-0363-2014. Published in FDA’s Enforcement Report on Nov 27, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 27, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4126 units USA; 20449 inits Internationally how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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
4126 units USA; 20449 inits Internationally, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model FL14E B01008 B05307 B08323 B11351 B14383 B17357 B20142 B23142 B01010 B05308 B08324 B11352 B14384 B17358 B20143 B23143 B01022 B05309 B08325 B11353 B14385 B17358 B20144 B23144 B01045 B05310 B08326 B11354 B14386 B17359 B20145 B23145…
Every code shown here, 2,000 characters
Model FL14E B01008 B05307 B08323 B11351 B14383 B17357 B20142 B23142 B01010 B05308 B08324 B11352 B14384 B17358 B20143 B23143 B01022 B05309 B08325 B11353 B14385 B17358 B20144 B23144 B01045 B05310 B08326 B11354 B14386 B17359 B20145 B23145 B01045 B05311 B08327 B11355 B14387 B17359 B20146 B23146 B01323 B05312 B08328 B11356 B14388 B17360 B20147 B23147 B01356 B05313 B08329 B11357 B14389 B17360 B20148 B23148 B01392 B05314 B08330 B11358 B14390 B17361 B20149 B23149 B01433 B05315 B08331 B11359 B14391 B17361 B20150 B23150 B01434 B05316 B08332 B11360 B14392 B17362 B20151 B23151 B01465 B05317 B08333 B11361 B14393 B17362 B20152 B23152 B01466 B05318 B08334 B11362 B14394 B17363 B20153 B23153 B01467 B05319 B08335 B11363 B14395 B17363 B20154 B23154 B01470 B05320 B08336 B11364 B14396 B17364 B20155 B23155 B01542 B05321 B08337 B11365 B14397 B17364 B20156 B23156 B01597 B05322 B08338 B11366 B14398 B17365 B20157 B23157 B01598 B05323 B08339 B11367 B14399 B17365 B20158 B23158 B01602 B05324 B08340 B11368 B14400 B17366 B20159 B23159 B01729 B05325 B08341 B11369 B14401 B17366 B20160 B23160 B01779 B05326 B08342 B11370 B14402 B17367 B20161 B23161 B01780 B05327 B08343 B11371 B14403 B17367 B20162 B23162 B01781 B05328 B08344 B11372 B14404 B17368 B20163 B23163 B01995 B05329 B08345 B11373 B14405 B17368 B20164 B23164 B01996 B05330 B08346 B11374 B14406 B17369 B20165 B23165 B01997 B05331 B08347 B11375 B14407 B17369 B20166 B23166 B01998 B05332 B08348 B11376 B14408 B17370 B20167 B23167 B01999 B05333 B08349 B11377 B14409 B17370 B20168 B23168 B02000 B05334 B08350 B11378 B14410 B17371 B20169 B23169 B02001 B05335 B08351 B11379 B14411 B17371 B20170 B23170 B02002 B05336 B08352 B11380 B14412 B17372 B20171 B23171 B02013 B05337 B08353 B11381 B14413 B17372 B20172 B23172 B02014 B05338 B08354 B11382 B14414 B17373 B20173 B23173 B02015 B05339 B08355 B11383 B14415 B17373 B20174 B23174 B02016 B05340 B08356 B11384 B14416 B17374 B20175 B23175 B02017 B05341 B08357 B11385 B14417 B17374 B20176 B23176 B02018 B05342 B08358 B11386…
FDA’s list runs to 177,782 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 23, 2013.
- FDA classified it on Nov 19, 2013.
- FDA’s Enforcement Report published it on Nov 27, 2013.
- FDA terminated it on May 16, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 177,782 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.