RegWardenFDA facility compliance records
Company

INSTRUMENTATION INDUSTRIES, INCORPORATED

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2015: 1 recalls1’121’13’141’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “INSTRUMENTATION INDUSTRIES, INCORPORATED — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2518436-instrumentation-industries-incorporated/

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