The Spirit Plus Bed
Medical device recall Z-0438-2019. 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.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 50 states named in where it went
- 20,030 total 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?
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 Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
20,030 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 026192 026510 026511 026516 026517 026518 034095 034096 034097 034098 034099 034517 035212 035213 035214 035215 035216 035217 035218 035219 035220 035221 035222 035223 035224 035225 035226 036935 036936 036937 036938 036939…
Every code shown here, 1,997 characters
Serial Numbers: 026192 026510 026511 026516 026517 026518 034095 034096 034097 034098 034099 034517 035212 035213 035214 035215 035216 035217 035218 035219 035220 035221 035222 035223 035224 035225 035226 036935 036936 036937 036938 036939 036940 036941 037995 037996 037997 037998 037999 038000 038001 038002 038003 038004 038005 038006 038126 038127 038128 039790 039791 041998 042590 044486 045322 045910 045911 045912 045913 045914 045915 045916 047581 048338 048339 048340 048341 048342 048344 048345 048346 048347 048348 034424 034425 034518 034519 034520 034521 034522 034523 034524 034525 034526 034527 034528 034529 039359 039447 039448 039449 039450 039451 039452 041416 041417 041418 041419 041420 041421 041422 041423 041424 041425 041870 041871 041872 041873 041874 041875 041876 041877 041878 041879 041880 041881 041882 041883 041884 041885 042250 042251 042252 042253 042254 042255 042256 042257 042258 042259 044754 038909 039561 044713 044714 044715 044716 044717 044718 044719 044720 044721 044722 044723 044724 044725 044726 044727 044728 044729 044730 044731 044732 044733 044734 044735 044736 044737 044738 044739 044740 022903 022904 022905 034445 034446 035133 035134 035135 035136 035137 035138 035139 035140 035141 035142 035143 035144 035145 035146 035147 035148 035149 035150 038726 038727 038728 038729 038730 038731 038732 038733 038734 038735 038736 038737 038738 038739 038740 038741 038742 038743 038744 038745 038746 038747 038748 038749 038750 038751 038752 038753 027260 027261 027262 027263 027264 022224 022225 022226 022227 022228 022229 022231 022232 022233 022613 022614 022615 022616 022617 022618 022619 022620 022621 022622 022623 022624 022625 022626 022627 022628 022629 022630 022631 022632 022633 022634 022635 022636 022637 022638 022639 022640 022641 022642 022643 022644 022645 022646 022647 022648 022649 022650 022651 022652 022653 022654 022655 022656 022657 022658 022659 022660 022661 022662 022663 022664 022665 022666 022667 022668 022669…
FDA’s list runs to 18,937 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 18,937 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.