Hearth Record

Power-LOAD Cot Fastening System

Medical device recall Z-1389-2018. Published in FDA’s Enforcement Report on Apr 25, 2018.

FDA’s own record, on accessdata.fda.gov

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 Apr 25, 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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.

4724, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Serial numbers: 160139700 160139701 160139702 160139704 160139705 160139706 160139707 160139708 160139709 160139710 160139711 160139712 160139713 160139714 160139743 160139744 160139745 160139746 160139747 160139748 160139749 160139750…

Every code shown here, 1,996 characters

Serial numbers: 160139700 160139701 160139702 160139704 160139705 160139706 160139707 160139708 160139709 160139710 160139711 160139712 160139713 160139714 160139743 160139744 160139745 160139746 160139747 160139748 160139749 160139750 160139751 160139752 160139753 160139754 160139755 160139756 160139804 160139805 160139806 160139807 160139808 160139809 160139810 160139811 160139812 160139813 160139814 160139815 160139816 160139817 160139818 160139819 160139820 160139821 160139822 160139823 160139824 160139825 160139826 160139827 160139828 160139829 160139830 160139831 160139832 160139833 160139834 160139835 160139836 160139837 160139838 160139839 160139894 160139895 160139896 160139897 160139898 160139899 160139900 160139901 160139902 160139903 160139904 160139905 160139906 160139907 160139908 160139909 160139910 160139911 160139912 160139913 160139914 160139915 160139916 160139917 160139918 160139919 160139920 160139921 160139922 160139923 160139924 160139925 160139926 160139927 160139928 160139929 160139930 160139931 160139982 160139983 160139984 160139985 160139986 160139987 160139988 160139989 160139990 160139991 160139992 160139993 160139994 160139995 160139996 160139997 160139998 160139999 160140027 160140028 160140029 160140030 160140031 160140032 160140033 160140034 160140035 160140036 160140037 160140038 160140039 160140040 160140041 160140042 160140043 160140044 160140045 160140046 160140047 160140048 160140049 160140075 160140076 160140077 160140078 160140079 160140080 160140081 160140082 160140083 160140084 160140085 160140086 160140087 160140088 160140089 160140090 160140091 160140127 160140128 160140129 160140130 160140131 160140132 160140133 160140134 160140135 160140136 160140137 160140138 160140139 160140140 160140141 160140142 160140143 160140144 160140145 160140146 160140340 160140341 160140342 160140343 160140344 160140345 160140346 160140347 160140348 160140349 160140350 160140351 160140352 160140353 160140354 160140395 160140396 160140397…

FDA’s list runs to 106,446 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Mar 12, 2018.
  • FDA classified it on Apr 17, 2018.
  • FDA’s Enforcement Report published it on Apr 25, 2018.
  • FDA terminated it on May 12, 2020.
Source:

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.
Source:

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 106,446 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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