RegWardenFDA facility compliance records
Recall

Class II — Maquet Cardiovascular, LLC

Recalling firmMaquet Cardiovascular LLC
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonSome batches of product were not sterilized to their minimum sterilization specification.
ProductVASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Quantity235 units
DistributionWorldwide distribution - US Nationwide and the countries of Brazil, China.
Initiated2023-03-06
Classified2023-04-04
Recall numberZ-1337-2023
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 — Maquet Cardiovascular, LLC (Z-1337-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91764/

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