RegWardenFDA facility compliance records
Facility

INSTRUMENTATION INDUSTRIES, INCORPORATED

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2015: 1 recalls; 2016: 1 inspections; 2021: 1 inspections1’121’13’141’151’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (3)
  • Inspections (2)

Devices registered here (1)

  • Ventilator, Continuous, Facility Use
    Product code CBK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5895

Recalls & enforcement

  • Class IITerminated2015-09-23
    As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur betwe…
  • Class IITerminated2013-11-13
    Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.
  • Class IITerminated2012-09-07
    Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

FDA inspections (2)

  • NAI2021-12-13
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2016-03-15
    Voluntary 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. “INSTRUMENTATION INDUSTRIES, INCORPORATED (FEI 2518436) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2518436-instrumentation-industries-incorporated/

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