Z-2271-2026Class II

Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

Name: Z-2271-2026 Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Creator: Covidien LLC
Published: 2026-04-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-04-23 / Open, Classified

FDA source

Covidien LLC began a recall of Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 on 2026-04-23. FDA classified it as Class II and gives the reason as "Temperature probe devices lack FDA clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2271-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-23
Posted: 2026-05-29
Recalling firm: Medtronic, Inc.
Product: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Product code: BZT Stethoscope, Esophageal, With Electrical Conductors
Reason for recall: Temperature probe devices lack FDA clearance.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 23,000 units
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 codes and lots: UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2271-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2272-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2273-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code BZT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)