FDAClass II · Medical device · Recalled June 10, 2026

Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF recall — Covidien LLC

Hazard: Temperature probe devices lack FDA clearance.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2271-2026
Brand: Covidien
Classification: Class II
Units affected: 23,000 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

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

Companies & origin

Recalling firm location: Boulder, CO, United States
Firm address: 6135 Gunbarrel Ave, 80301-3214

Identifying details (verbatim from the notice)

Product codes / lots: UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
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.
Firm notified the public via: E-Mail
FDA event ID: 98859
Recall initiated: April 23, 2026
FDA classified: May 29, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

Report a data error on this page