Mon-a-Therm recallZ-2271-2026 · Covidien LLC · initiated Apr 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Temperature probe devices lack FDA clearance.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 23, 2026 Covidien (subsidiary of Medtronic) issued a Urgent Medical Device Recall Notification to affected consignees via USPS. Covidien ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots. 2. Return all unused product(s) from the affected lots in your inventory to Medtronic as described in the Customer Confirmation Form. 3. Share this notice with all relevant personnel within your organization, and with any organization to which the potentially affected product from the specified lots has been transferred or distributed. 4. Please complete and return the enclosed Customer Confirmation Form to [email protected] even if you do not have unused inventory.
Recall details
- Recall number
- Z-2271-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 23, 2026
- Posted by the FDA
- May 29, 2026
- Recalling firm
- Covidien LLC
- Quantity
- 23,000 units
- Product code
- BZT
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
Product description
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Code information (models, lots, serial numbers)
UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mon-a-Therm 90042Covidien LP · STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98859).
- Z-2272-2026 · Open, ClassifiedCovidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
- Z-2273-2026 · Open, ClassifiedCovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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