RegWardenFDA facility compliance records
Recall

Class II — Angiodynamics, Inc.

Recalling firmANGIODYNAMICS, INC
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonSpecific 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.
ProductSolero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Quantity26 US, 4 OUS
DistributionDomestic distribution Nationwide. Foreign distribution worldwide.
Initiated2021-07-20
Classified2021-09-08
Terminated2023-03-15
Recall numberZ-2437-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Angiodynamics, Inc. (Z-2437-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88444/

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