FDA Medical Device Recalls (openFDA)
Covidien LLC: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
- Recall number
- Z-2271-2026
- Recalling firm
- Covidien LLC
- Product
- Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
- Status
- Open, Classified
- Initiated
- 2026-04-23
- Posted
- 2026-05-29
- Terminated
- not on file
- Reason
- Temperature probe devices lack FDA clearance.
- 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 rs.gmbmitgfca@medtronic.com even if you do not have unused inventory.
- Quantity
- 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.
- Lot, serial or model codes
- UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZT
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28