Stethoscope, Esophageal, With Electrical Conductors
Anesthesiology · 21 CFR 868.1920
Recent MDR events
30 adverse event reports on file
- ESOPH STETH 400 SERIES 12 FRJan 2, 2026MalfunctionDeroyal Cientifica De Latinoamerica S.r.l9613793-2025-00014
- ESOPH STETH 400 SERIES 18 FR, 400 SERIES = 2 PRONGSAug 9, 2024MalfunctionDeroyal Cientifica De Latinoamerica S.r.l9613793-2023-00018
- ESOPH STETH 400 SERIES 9 FRAug 7, 2024InjuryDeroyal Cientifica De Latinoamerica S.r.l9613793-2023-00001
- ESOPH STETH 400 SERIES 18 FR, 400 SERIESAug 7, 2024InjuryDeroyal Cientifica De Latinoamerica S.r.l9613793-2023-00002
- MON-A-THERMSep 13, 2022MalfunctionMmj Sa De Cv (usd)2936999-2022-00832
- MedlineNov 16, 2021InjuryMedline Industruies Lp1417592-2021-00202
- MedlineNov 16, 2021InjuryMedline Industruies Lp1417592-2021-00203
- ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSORJul 6, 2021Malfunction9613793-2021-00014
- ESOPHAGEAL STETHOSCOPE, 12 FRENCHNov 6, 2019MalfunctionDeroyal Cientifica De Latinoamerica S.r.l.9613793-2019-00004
- ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORApr 10, 2019MalfunctionDeroyal Cientifica De Latinoamerica S.r.l.9613793-2019-00002
Event type breakdown
Recalls
4 recall events for this product code
- Covidien LLCOpen, ClassifiedMay 29, 2026
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM
Temperature probe devices lack FDA clearance.
Z-2271-2026 · View FDA record ↗ - Covidien LLCOpen, ClassifiedMay 29, 2026
Covidien Mon-a-Therm General Purpose Temperature Probe
Temperature probe devices lack FDA clearance.
Z-2272-2026 · View FDA record ↗ - Covidien LLCOpen, ClassifiedMay 29, 2026
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr
Temperature probe devices lack FDA clearance.
Z-2273-2026 · View FDA record ↗ - Cincinnati Sub-Zero Products IncTerminatedJan 11, 2012
Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe u
Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
Z-0372-2012 · View FDA record ↗
Registered firms
36 firms currently registered for this product code
Isomedix Operations Inc.
SAN DIEGO, CA, US
Starboard Medical, Inc.
Irvine, CA, US
Covidien
Ciudad Juarez Chihuahua, MX
Covidien
Lafayette, CO, US
Deroyal Cientifica De Latinoamerica S.r.l.
LA AURORA, HEREDIA, CR
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Starboard Medical (jiangsu) Co. Ltd.
Sheyang Jiangsu, CN
Isomedix Operations Inc.
S Plainfield, NJ, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Sterigenics U.s., Llc
Santa Teresa, NM, US
Deroyal Industries, Inc.
POWELL, TN, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Cardiocommand, Inc.
TAMPA, FL, US
510(k) clearances
46 clearances for this product code
- Covidien, LLCDec 29, 2025
K251025 · Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- Deroyal Industries, Inc.Apr 2, 2020
K193027 · Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
- Starboard Medical, LLCJun 16, 2014
K140134 · ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
- Starboard Medical, LLCApr 12, 2012
K111050 · ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
- Truer Medical, Inc.Sep 17, 2009
K092716 · ESOPHAGEAL STETHOSCOPE
- Cincinnati Sub-Zero Products, Inc.Dec 13, 2007
K072621 · ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
- Novamed, LLCSep 5, 2006
K062020 · LIFESOUND ESOPHAGEAL STETHOSCOPE
- Shore Medical, Inc.Sep 1, 1998
K982193 · ESOPHAGEAL STETHOSCOPE