CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Terumo HX2 Temperature Management System recalled
Terumo Cardiovascular Systems is recalling Terumo HX2 Temperature Management System, distributed nationwide in the US. The recall was initiated on 16 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1416-2018
- FDA event ID
- 79652
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 16 Mar 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +32 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Update to cooler-heater cleaning instructions.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Terumo HX2 Temperature Management System recalled?
Yes. Terumo Cardiovascular Systems recalled Terumo HX2 Temperature Management System on 16 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1416-2018.
Why was it recalled?
Update to cooler-heater cleaning instructions.
Which lots are affected?
All Lot Codes
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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