Ventilator Tubing

Recall Insight

This FDA Devices action (record #Z-0269-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on September 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Instrumentation Industries Inc is listed as the recalling firm, operating out of Bethel Park, PA. Federal records indicate 567 units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.