RegWardenFDA facility compliance records
Recall

Class II — Maquet Cardiovascular Us Sales, Llc

Recalling firmMaquet Cardiovascular LLC
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonMaquet Compressor Mini may deliver compressed air at a temperature higher than specified.
ProductCompressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
Quantity237 units
DistributionWorldwide Distribution US, Canada and Japan.
Initiated2013-12-05
Classified2014-01-28
Terminated2015-02-05
Recall numberZ-0848-2014
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 Us Sales, Llc (Z-0848-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67100/

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