“Terumo Sarns TCM II Temperature Monitor Recall: Update Cleaning Instructions.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71686-terumo-sarns-tcm-ii-temperature-monitor-recall-update-cleaning-instructions. Based on FDA recall #Z-1418-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1418-2018%22&limit=1).
The FDA announced on March 16, 2018, that Terumo Cardiovascular Systems Corporation is recalling Sarns TCM II devices due to a need for updated cooler-heater cleaning instructions. The agency issued recall number Z-1418-2018 for the Class II voluntary recall.
The recall addresses the need to update cooler-heater cleaning instructions for the Sarns TCM, which is indicated for controlling and monitoring patient temperature.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Philips Telemetry Monitor 5500 1.4 GHz Recall (June 5, 2026) and Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026).
How to tell if you have this one
Check for catalog numbers 4415, 4416, 164925, 164930, 164935, or 164940 on the device. The device is indicated for controlling and monitoring patient temperature.
Brand
Terumo
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
Recall number
Product, codes & lots
Quantity
Z-1416-2018
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.; All Lot Codes
2393 this total is for all products
Z-1417-2018
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .; All Lot Codes
2393- total for all products
Z-1418-2018
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .; All Lot Codes
2393- total for all products
Based on the official FDA remedy
What to do — step by step
Review Cleaning Instructions
Check the device for updated cleaning instructions as provided by Terumo.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1418-2018 (March 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1418-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.