Z-2271-2026 Class II Ongoing
FDA device recall Z-2271-2026 was initiated by Covidien LLC on April 23, 2026 and is designated Class II. Reason for recall: Temperature probe devices lack FDA clearance. The recall status is ongoing. Affected quantity: 23,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- April 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,000 units
Product Description
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Reason for Recall
Temperature probe devices lack FDA clearance.
Distribution Pattern
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.
Code Information
UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,