Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2271-2026·Announced 2026-06-10

Covidien esophageal stethoscope temperature sensors lack FDA clearance

Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall arising from a regulatory clearance gap with no product defect or hazard described in the source, which fits the precautionary Moderate band.

Plain-English summary

The Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM, REF 90042, UDI 30884521820900, is being recalled. The action covers 23,000 units across the lots listed in the recall notice.

The stated reason is that the temperature probe devices lack FDA clearance. The FDA classified the action as Class II. The source does not describe any defect in the devices or any resulting hazard.

Distribution was nationwide in the United States across a large number of states. The devices are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF number, UDI and lot numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Manufacturer: Covidien LLC
Category: Medical Device — Temperature probe
Hazard: regulatory-clearance
unapproved-device
class-ii
Affected units: 23,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX
25E1324JZX
25H0920JZX

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · regulatory clearance