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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien MonaTherm General Purpose Temperature Probe

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 Class 2 Device Recall Covidien MonaTherm General Purpose Temperature Probesee related information
Date Initiated by FirmApril 23, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2273-2026
Recall Event ID 98859
Product Classification Stethoscope, esophageal, with electrical conductors - Product Code BZT
ProductCovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Code Information UDI: 10884521828391, 30884521828395/ Lot: 24D1130JZX 25A1086JZX 25E1332JZX 25I1054JZX 24D1133JZX 25A1087JZX 25F0946JZX 25I1055JZX 24E1015JZX 25A1088JZX 25F0947JZX 25I1056JZX 24E1017JZX 25D0379JZX 25F0948JZX 25I1057JZX 24E1018JZX 25D0380JZX 25F0949JZX 25I1058JZX 24L0848JZX 25D0381JZX 25F0950JZX 25I1059JZX 24L0850JZX 25D1271JZX 25F0953JZX 25I1061JZX 25A1069JZX 25D1272JZX 25F0954JZX 25K1129JZX 25A1070JZX 25D1273JZX 25G1163JZX 25K1130JZX 25A1072JZX 25E1263JZX 25H0935JZX 25K1131JZX 25A1075JZX 25E1264JZX 25H0936JZX 25L0542JZX 25A1076JZX 25E1265JZX 25H0938JZX 25L0545JZX 25A1077JZX 25E1326JZX 25H0939JZX 25L0899JZX 25A1082JZX 25E1329JZX 25H0940JZX 25L0901JZX 25A1084JZX 25E1331JZX 25H0942JZX 25L0903JZX 25A1085JZX
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 Commerce128,900 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.
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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