← FDA ENFORCEMENT
Z-2271-2026Class II

Covidien LLC

Recalling firm
Covidien LLC
Product type
Device
Status
Ongoing
Report date
2026-06-10
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 state
CO
Product quantity
23,000 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Temperature probe devices lack FDA clearance.

Product description

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

Code / lot info

UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.