Class II U.S. Food and Drug Administration

Covidien Mon-a-Therm general purpose recall: Temperature probe devices lack FDA clearance

Recall published 5 months ago

Temperature probe devices lack FDA clearance.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Temperature probe devices lack FDA clearance.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2273-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Covidien LLC
Product type
Medical devices
Units affected
128,900 units
Distribution
Nationwide
Made in
United States
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
UPC codes
10884521828391, 30884521828395

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10884521828391
  • 30884521828395

Model or item number

On the rating label, the box or the instruction sheet.

  • 90050 — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Covidien LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Covidien LLC — 6135 Gunbarrel Ave, Boulder, CO, 80301-3214

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Covidien LLC medical devices recalled?

Temperature probe devices lack FDA clearance. Temperature probe devices lack FDA clearance.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10884521828391, 30884521828395; model number 90050 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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