ClearanceBrief
Recall Z-2273-2026 ยท BZT Stethoscope, Esophageal, With Electrical Conductors

Covidien LLC

Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

DateMay 29, 2026 (initiated Apr 23, 2026)
StatusOpen, Classified
ReasonTemperature probe devices lack FDA clearance.
Root causeUnder Investigation by firm
ActionOn April 23, 2026 Covidien (subsidiary of Medtronic) issued a Urgent Medical Device Recall Notification to affected consignees via USPS. Covidien ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots. 2. Return all unused product(s) from the affected lots in your inventory to Medtronic as described in the Customer Confirmation Form. 3. Share this notice with all relevant personnel within your organization, and with any organization to which the potentially affected product from the specified lots has been transferred or distributed. 4. Plea
Quantity128,900 units
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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.