FDA DevicesClass II
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: ...
Published: June 10, 2026Recall ID: Z-2271-2026Category: devicesCountry: US
Reason for Recall / Hazard
Temperature probe devices lack FDA clearance.
Product Description & Identification
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: 90042
Additional Source Details
| Field | Value |
|---|---|
| City | Boulder |
| State | CO |
| Event id | 98859 |
| Address 1 | 6135 Gunbarrel Ave |
| Code info | UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX, |
| Postal code | 80301-3214 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 23,000 units |
| Reason for recall | Temperature probe devices lack FDA clearance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260423 |
| Initial firm notification | |
| Center classification date | 20260529 |
Overview
- Recalling FirmCovidien LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.