Permobil powered wheelchairs
Medical device recall Z-3178-2018. Published in FDA’s Enforcement Report on Sep 26, 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 Sep 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3134 units 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?
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
3134 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) M300 PS, Serial numbers: 2572023019 2572000069 2572000403 2572000293 2572000358 2572000298 2572000359 2572000089 2579000025 2572018895 2572018959 2572000487 2572000491 2572000488 2572000492 2572000489 2579000027 2572000490 2572000493…
Every code shown here, 1,998 characters
(a) M300 PS, Serial numbers: 2572023019 2572000069 2572000403 2572000293 2572000358 2572000298 2572000359 2572000089 2579000025 2572018895 2572018959 2572000487 2572000491 2572000488 2572000492 2572000489 2579000027 2572000490 2572000493 2572000736 2572000367 2572000766 2572000816 2572000905 2572000924 2572000765 2572000299 2572006070 2572017706 2572024924 2572000735 2572024257 2572003615 2572001137 2572001149 2572001168 2572001169 2572001289 2572001170 2572001324 2572015685 2572015835 2572000402 2572001470 2572001546 2572001649 2572001650 2572001468 2572001471 2572001739 2572001798 2572001757 2572001851 2572001758 2572001379 2572001829 2572001859 2572001756 2572001860 2572002162 2572002521 2572002696 2572002941 2572002960 2572002085 2572001738 2572002163 2572002275 2572002054 2572002277 2572002449 2572002695 2572002697 2572002940 2572003044 2572003043 2572003045 2572003027 2572003231 2572003367 2572003402 2572003403 2572003550 2572003515 2572003565 2572003618 2572003804 2572003863 2572004017 2572024869 2572024934 2572003867 2572004018 2572004053 2572024343 2572024870 2572024318 2572024300 2572004211 2572004325 2572004369 2572004372 2572004312 2572004371 2572024234 2572023921 2572004542 2572004373 2579000258 2572004612 2572004613 2572004618 2572024388 2572023131 2579000839 2572023068 2572000367 2572004760 2572004968 2572004707 2572004967 2572005018 2572005019 2572004621 2572005021 2572005057 2572005058 2572005055 2572005059 2572005062 2572005064 2572005056 2572005210 2572005213 2572005211 2572005214 2572005218 2572005337 2572005412 2572005557 2572005602 2572005617 2572005618 2572005651 2572005688 2572005690 2572005691 2572005739 2572000401 2572000680 2572002161 2572001136 2572000812 2572001181 2572001138 2572006042 2572006078 2572006095 2572006129 2572006146 2579000282 2572006301 2572006440 2572006272 2572006393 2572006424 2572020015 2572019837 2572006702 2572006483 2572006471 2572006531 2572006532 2572006703 2572006772 2572006484 2572006805 2572006806 2572006817…
FDA’s list runs to 19,578 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.
Worldwide Distribution - US Nationwide
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.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 15, 2018.
- FDA classified it on Sep 14, 2018.
- FDA’s Enforcement Report published it on Sep 26, 2018.
- FDA terminated it on May 3, 2021.
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.
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 19,578 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.