Terumo HX2 Temperature Management System Recall: Update to Cleaning Instructions

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Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Terumo is recalling its HX2 Temperature Management System used in open heart surgery because cleaning instructions need updating. This affects all units sold with the catalog number 809810.

Why it’s dangerous

The system requires updated cleaning instructions to ensure safe temperature regulation during open heart surgery. Improper cleaning could lead to temperature issues affecting patient safety.

Who’s affected

Healthcare professionals using the Terumo HX2 Temperature Management System during open heart surgery are affected. Patients undergoing this procedure are at risk if the system is not properly maintained.

How to tell if you have this one

Check for the catalog number 809810 on the device. All units produced are affected by this recall.

Brand
Terumo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the catalog number 809810 on the Terumo HX2 Temperature Management System.

✎ GovInfoNow

Questions people ask

Why is this being recalled?

The recall is due to an update to the cooler-heater cleaning instructions for the Terumo HX2 Temperature Management System used in open heart surgery.

Is there a risk of serious injury?

The recall does not mention a risk of serious injury; it focuses on updated cleaning instructions for safety.

How do I know if I have the recalled product?

All units with catalog number 809810 are affected by this recall.

Take action

Contact Terumo

We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1416-2018 — Terumo Terumo

Hello,

I own a Terumo that is covered by recall Z-1416-2018 from Terumo.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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-1416-2018 (March 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1416-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

Terumo Cardiovascular Systems Corporation recalls Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated

Lower-risk recall