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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67100

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 05, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiovascular Us Sales, Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Compressor 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.

Z-0848-2014
Recall number
Z-0848-2014
Initiated
December 05, 2013
Classification
Class II
Status
Terminated
Quantity
237 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

Code information

Part number 6481779

Distribution pattern

Worldwide Distribution US, Canada and Japan.