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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien MonaTherm Esophageal Stethoscope with Temperature Sensor

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 Class 2 Device Recall Covidien MonaTherm Esophageal Stethoscope with Temperature Sensorsee related information
Date Initiated by FirmApril 23, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2271-2026
Recall Event ID 98859
Product Classification Stethoscope, esophageal, with electrical conductors - Product Code BZT
ProductCovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Code Information UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
FEI Number 2936999
Recalling Firm/
Manufacturer		 Covidien LLC
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactTechnical and Clinical Support
800-255-6774 Ext. 6
Manufacturer Reason
for Recall		Temperature probe devices lack FDA clearance.
FDA Determined
Cause 2		Under 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. Please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory.
Quantity in Commerce23,000 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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