SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Recall Insight

This FDA Devices action (record #Z-0514-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on December 22, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien, LP is listed as the recalling firm, operating out of North Haven, CT. Federal records indicate 66 devices units are affected.

The documented reason for this recall is: Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable di… Distribution data in the federal record shows the product reached: The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.. 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 4 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.