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.
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 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
- 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
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.
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