Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Summary
The FDA issued a Class II for Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 by Covidien LLC. Reason: Temperature probe devices lack FDA clearance..
Details
Source
Device Recall
External ID
Z-2273-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Lot/Code Info: 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
Quantity Affected: 128,900 units
Reason for Recall
Temperature probe devices lack FDA clearance.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-23
Company
Boulder, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien LLC has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien LLC have FDA actions?
Covidien LLC has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2273-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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