RegWardenFDA facility compliance records
Facility

MIDMARK CORPORATION

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2016: 1 inspections; 2018: 1 inspections; 2026: 2 recalls1’131’14’151’16’171’18’19’20’21’22’23’24’252’26
  • Recalls (4)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2026-08-21
    A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
  • Class IIOngoing2026-07-20
    A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
  • Class IITerminated2014-09-04
    Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
  • Class IITerminated2013-09-20
    An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control…

FDA inspections (2)

  • VAI2018-04-02
    Voluntary Action Indicated · Postmarket Assurance: Devices · citations posted
  • NAI2016-12-09
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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

Cite this record

RegWarden. “MIDMARK CORPORATION (FEI 1523530) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1523530-midmark-corporation/

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