The Recall Desk
ModerateFDA (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.

What this means for you

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

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.

Related recalls

Same category