FDA recall Z-2271-2026

Product

Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

Reason for recall

Temperature probe devices lack FDA clearance.

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.

Key facts

Status

Ongoing

Initiation date

2026-04-23

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2271-2026