Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator
Medical device recall Z-0872-2015. Published in FDA’s Enforcement Report on Dec 31, 2014.
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 Dec 31, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 138,446 units distributed globally 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 firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
138,446 units distributed globally, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
The following serial numbers are affected by this recall: (Also, see attachment 1) 10CSZ430001 10FSZ622001 10JSZ621110 11BSZ621620 11HSZ620426 11LSZ620172 12CSZ622081 10CSZ430002 10FSZ622002 10JSZ621111 11BSZ621621 11HSZ620427 11LSZ620173…
Every code shown here, 1,991 characters
The following serial numbers are affected by this recall: (Also, see attachment 1) 10CSZ430001 10FSZ622001 10JSZ621110 11BSZ621620 11HSZ620426 11LSZ620172 12CSZ622081 10CSZ430002 10FSZ622002 10JSZ621111 11BSZ621621 11HSZ620427 11LSZ620173 12CSZ622082 10CSZ430003 10FSZ622003 10JSZ621112 11BSZ621622 11HSZ620428 11LSZ620174 12CSZ622083 10CSZ430004 10FSZ622004 10JSZ621113 11BSZ621623 11HSZ620429 11LSZ620175 12CSZ622084 10CSZ430005 10FSZ622005 10JSZ621114 11BSZ621624 11HSZ620430 11LSZ620176 12CSZ622085 10CSZ430006 10FSZ622006 10JSZ621115 11BSZ621625 11HSZ620431 11LSZ620177 12CSZ622086 10CSZ430007 10FSZ622007 10JSZ621116 11BSZ621626 11HSZ620432 11LSZ620178 12CSZ622087 10CSZ430008 10FSZ622008 10JSZ621117 11BSZ621627 11HSZ620433 11LSZ620179 12CSZ622088 10CSZ430009 10FSZ622009 10JSZ621118 11BSZ621628 11HSZ620434 11LSZ620180 12CSZ622089 10CSZ430010 10FSZ622010 10JSZ621119 11BSZ621629 11HSZ620435 11LSZ620181 12CSZ622090 10CSZ430011 10FSZ622011 10JSZ621120 11BSZ621630 11HSZ620436 11LSZ620182 12CSZ622091 10CSZ430012 10FSZ622012 10JSZ621121 11BSZ621631 11HSZ620437 11LSZ620183 12CSZ622092 10CSZ430013 10FSZ622013 10JSZ621122 11BSZ621632 11HSZ620438 11LSZ620184 12CSZ622093 10CSZ430014 10FSZ622014 10JSZ621123 11BSZ621633 11HSZ620439 11LSZ620185 12CSZ622094 10CSZ620001 10FSZ622015 10JSZ621124 11BSZ621634 11HSZ620440 11LSZ620186 12CSZ622095 10CSZ620002 10FSZ622016 10JSZ621125 11BSZ621635 11HSZ620441 11LSZ620187 12CSZ622096 10CSZ620003 10FSZ622017 10JSZ621126 11BSZ621636 11HSZ620442 11LSZ620188 12CSZ622097 10CSZ620004 10FSZ622018 10JSZ621127 11BSZ621637 11HSZ620443 11LSZ620189 12CSZ622098 10CSZ620005 10FSZ622019 10JSZ621128 11BSZ621638 11HSZ620444 11LSZ620190 12CSZ622099 10CSZ620006 10FSZ622020 10JSZ621129 11BSZ621639 11HSZ620445 11LSZ620191 12CSZ622100 10CSZ620007 10FSZ622021 10JSZ621130 11BSZ621640 11HSZ620446 11LSZ620192 12CSZ622101 10CSZ620008 10FSZ622022 10JSZ621131 11BSZ621641 11HSZ620447 11LSZ620193 12CSZ622102 10CSZ620009 10FSZ622023 10JSZ621132 11BSZ621642 11HSZ620448…
FDA’s list runs to 637,779 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 product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.
These words name no state.
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 31, 2014.
- FDA classified it on Dec 24, 2014.
- FDA’s Enforcement Report published it on Dec 31, 2014.
- FDA terminated it on Feb 7, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Invacare Corporation, of Elyria, OH.
- 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 637,779 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.