Hearth Record

Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500…

Medical device recall Z-0005-2018. Published in FDA’s Enforcement Report on Oct 11, 2017.

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 Oct 11, 2017. 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?

There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

Source:

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

Which ones are recalled?

Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR

5539 units, in FDA’s words.

Source:

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

Codes to check against yours

a) C300 CORPUS II, Serial Numbers: DOMESTIC: 43407264 43502593 43505689 2535000080 2535000452 2535000453 2535000717 2535001026 2535001168 2535001320 2535001707 2535001800 2535001950 2535002178 2535002183 2535002275 2535002281 2535002304…

Every code shown here, 1,997 characters

a) C300 CORPUS II, Serial Numbers: DOMESTIC: 43407264 43502593 43505689 2535000080 2535000452 2535000453 2535000717 2535001026 2535001168 2535001320 2535001707 2535001800 2535001950 2535002178 2535002183 2535002275 2535002281 2535002304 2535002628 2535002986 2535003299 2535003587 2535003669 2535003720 2535003741 2535003742 2535003743 2535003744 2535003745 2535003785 2535003786 2535003787 2535003790 2535003791 2535003792 2535003793 2535003837 2535003838 2535003839 2535003841 2535003844 2535003845 2535003846 2535003847 2535003848 2535003849 2535003850 2535003851 2535003852 2535003853 2535003854 2535003855 2535003856 2535003917 2535003918 2535003921 2535003922 2535003923 2535003924 2535003925 2535003926 2535003938 2535003939 2535003940 2535003941 2535003967 2535003968 2535003969 2535003971 2535003986 2535003987 2535003988 2535003989 2535003990 2535003999 2535004000 2535004001 2535004002 2535004003 2535004025 2535004026 2535004027 2535004079 2535004080 2535004081 2535004082 2535004085 2535004086 2535004087 2535004088 2535004089 2535004090 2535004091 2535004092 2535004093 2535004094 2535004095 2535004129 2535004140 2535004142 2535004143 2535004157 2535004158 2535004159 2535004174 2535004175 2535004176 2535004177 2535004178 2535004179 2535004180 2535004181 2535004182 2535004183 2535004184 2535004210 2535004211 2535004212 2535004213 2535004214 2535004263 2535004264 2535004265 2535004266 2535004267 2535004268 2535004321 2535004322 2535004323 2535004324 2535004325 2535004326 2535004327 2535004328 2535004329 2535004330 2535004331 2535004366 2535004367 2535004368 2535004369 2535004370 2535004371 2535004407 2535004408 2535004409 2535004410 2535004411 2535004412 2535004502 2535004503 2535004504 2535004512 2535004513 2535004514 2535004515 2535004516 2535004517 2535004518 2535004519 2535004520 2535004533 2535004534 2535004535 2535004536 2535004569 2535004570 2535004571 2535004572 2535004573 2535004575 2535004576 2535004577 2535004578 2535004579 2535004580 2535004581 2535004582…

FDA’s list runs to 55,794 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.

Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE

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.

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 Sep 1, 2017.
  • FDA classified it on Oct 3, 2017.
  • FDA’s Enforcement Report published it on Oct 11, 2017.
  • FDA terminated it on May 4, 2021.
Source:

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

Who is recalling it?

  • Permobil, Ab, of Timra, Sweden.
  • 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 55,794 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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