The Spirit Select Bed
Medical device recall Z-0439-2019. Published in FDA’s Enforcement Report on Nov 21, 2018.
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 21, 2018. Copied from openFDA on Oct 20, 2026.
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?
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 025414 026524 026525 026526 026527 030552 030553 030554 030555 030556 027441 034418 034419 034420 041189 041190 042791 042792 042793 042794 042795 042796 042797 042798 042799 042800 042801 042802 042803 042804 042805 042806…
Every code shown here, 1,997 characters
Serial Numbers: 025414 026524 026525 026526 026527 030552 030553 030554 030555 030556 027441 034418 034419 034420 041189 041190 042791 042792 042793 042794 042795 042796 042797 042798 042799 042800 042801 042802 042803 042804 042805 042806 042807 042808 042809 042810 042811 042812 042813 042814 042815 042816 042817 042818 042819 042820 042821 042822 042823 042824 042825 042826 042827 042828 046459 046992 046993 047150 047151 048208 048209 048210 048211 048212 048213 048214 048215 048216 048217 048681 048682 032798 032799 032800 032801 032802 032803 032804 032805 032806 032807 032808 032809 032810 032811 032812 032813 032814 032815 032816 032817 032818 032819 032820 032821 032822 032823 032824 033942 033943 033944 034417 034530 034531 034532 034533 034534 034535 034536 034537 034538 034539 034579 034580 034581 035059 035174 035175 035207 035208 036925 036926 036927 037794 037795 037796 037797 038180 038181 038182 038183 038184 038185 038256 038257 038258 038259 038260 038261 038262 038263 038264 038265 038266 038436 038437 038438 038439 038440 038441 038442 038443 038444 038445 038446 038447 038448 038449 038450 038451 038452 038453 038454 038455 038456 038457 038458 038459 038595 038596 038597 038598 038599 038600 038601 038602 038603 038604 038605 038606 038607 038608 038761 038762 038763 038764 038765 038766 038767 038768 038769 038770 038771 038772 038773 038774 038775 038776 038777 038778 038779 038780 038781 038782 038783 038784 038785 038786 038787 038788 038789 038790 038791 038792 038793 038794 038795 038796 038797 038798 038799 038800 038801 038802 038803 038804 038805 038806 038807 038808 038809 038810 038811 038812 038813 038814 038815 038816 038817 038818 038930 038931 038932 038933 038934 038935 038936 038937 038938 038939 038940 038941 038942 038943 038944 038945 038946 038947 038948 038949 038950 038951 038952 038953 038954 038955 038956 038957 038958 038959 038960 038961 038962 038963 038964 038965 038966 038967 038968 038969 038970 038971 038972…
FDA’s list runs to 345,389 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.
The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Canada.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 8, 2018.
- FDA classified it on Nov 9, 2018.
- FDA’s Enforcement Report published it on Nov 21, 2018.
- FDA terminated it on Apr 28, 2020.
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 345,389 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.