Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2273-2026·Announced 2026-06-10

Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance

Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 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 general purpose temperature probe, size 9 Fr, REF 90050, is being recalled. The action covers 128,900 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 probes or any resulting hazard.

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

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

The recalled product

Product: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Manufacturer: Covidien LLC
Category: Medical Device — Temperature probe
Hazard: regulatory-clearance
unapproved-device
class-ii
Affected units: 128,900

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 (1)

UDI: 10884521828391

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