Solero Generator PG
Medical device recall Z-2439-2021. Published in FDA’s Enforcement Report on Sep 15, 2021.
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 15, 2021. 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
- 65 OUS 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?
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
65 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Nos. QBY0002623 QBY0002629 QBY0002857 QBY0002830 QBY0002843 QBY0002431 QBY0002715 QBY0002717 QBY0002731 QBY0002732 QBY0002744 QBY0002745 QBY0002363 QBY0002631 QBY0002834 QBY0001999 QBY0002000 QBY0002303 QBY0002353 QBY0002368…
Every code shown here, 726 characters
Serial Nos. QBY0002623 QBY0002629 QBY0002857 QBY0002830 QBY0002843 QBY0002431 QBY0002715 QBY0002717 QBY0002731 QBY0002732 QBY0002744 QBY0002745 QBY0002363 QBY0002631 QBY0002834 QBY0001999 QBY0002000 QBY0002303 QBY0002353 QBY0002368 QBY0002432 QBY0002575 QBY0002653 QBY0002782 QBY0002783 QBY0002784 QBY0002004 QBY0002346 QBY0002576 QBY0002655 QBY0002680 QBY0002694 QBY0002709 QBY0002712 QBY0002791 QBY0002794 QBY0001991 QBY0001996 QBY0002036 QBY0002058 QBY0002703 QBY0002826 QBY0002833 QBY0002510 QBY0002624 QBY0002048 QBY0002012 QBY0002015 QBY0002481 QBY0002513 QBY0002531 QBY0002532 QBY0002812 QBY0002821 QBY0002738 QBY0002739 QBY0002564 QBY0002656 QBY0002657 QBY0002676 QBY0002014 QBY0002355 QBY0002563 QBY0002630 QBY0002743
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.
Domestic distribution Nationwide. Foreign distribution worldwide.
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 Jul 20, 2021.
- FDA classified it on Sep 8, 2021.
- FDA’s Enforcement Report published it on Sep 15, 2021.
- FDA terminated it on Mar 15, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Angiodynamics, Inc., of Queensbury, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
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
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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.