Spirit One A-C Powered Hospital Bed
Medical device recall Z-1555-2016. Published in FDA’s Enforcement Report on May 4, 2016.
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 May 4, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 19 states named in where it went
- 143 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?
Customer complaints associated with faulty brake system
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Spirit One A-C Powered Hospital Bed
143 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MDL#: E341062; Serial Numbers: B5A00-029643 029644 029537 029538 029539 029412 029413 029092 029093 029430 029431 029432 029433 029411 029479 029480 029463 029658 029461 029462 027773 029536 029420 029421 029423 029424 029094 029095 029096…
Every code shown here, 1,044 characters
MDL#: E341062; Serial Numbers: B5A00-029643 029644 029537 029538 029539 029412 029413 029092 029093 029430 029431 029432 029433 029411 029479 029480 029463 029658 029461 029462 027773 029536 029420 029421 029423 029424 029094 029095 029096 029097 029098 029458 029459 027772 028853 028854 029563 029564 029639 029640 028835 030097 030099 028845 028846 028847 028848 029416 028003 029177 029418 029427 029428 029558 029559 029560 028834 029419 029429 029416 028840 028842 028843 028844 028836 028837 028838 028839 028849 028850 028851 028852 028841 028957 028958 028959 029460 029466 029467 029468 029415 029648 029460 029466 029645 029649 029650 029652 029654 029655 029657 029659 030096 030098 029467 029468 029656 029417 030154 030157 030158 030159 030161 030223 030225 030226 030354 030100 030152 030439; B5F00-029179 028654 028655 028656 028659 028660 028661 028663 028664 028793 028657 029540 029541 029646 029642 028788 029176 029175 029414 029178 029561 028216 029464 030151; B5C00-029182 029183 029184 029185 029186 029187 029188 029189
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.
US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK.
The states and territories these words name
19 states and territories.
Every one of them
- Alabama
- Arizona
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Kansas
- Louisiana
- Michigan
- Minnesota
- Missouri
- Nebraska
- New Jersey
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
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 Jul 2, 2015.
- FDA classified it on Apr 22, 2016.
- FDA’s Enforcement Report published it on May 4, 2016.
- FDA terminated it on Mar 24, 2017.
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.”
- 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
-
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.