FDA Medical devices recall ·
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM recall
- Recall number
- Z-2271-2026
- Date
- (initiated April 23, 2026)
- Company / brand
- Covidien, LP
6135 Gunbarrel Ave, Boulder, CO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23,000 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Why was it recalled?
Temperature probe devices lack FDA clearance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Illinois Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Utah Virginia Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2271-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.