Lower riskMedical device recall · FDA · Published January 19, 2018
Terumo Flowmeter Module Recall: Inaccurate Flow Readings May Cause Errors
Terumo recalls Flowmeter Module (accessory for Advanced Perfusion System 1) due to inaccurate flow readings that may not be easily detected during setup or use. Affected units have specific serial numbers.
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Take action
Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586
“Terumo Flowmeter Module Recall: Inaccurate Flow Readings May Cause Errors.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72124-terumo-flowmeter-module-recall-inaccurate-flow-readings-may-cause-errors. Based on FDA recall #Z-1478-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2018%22&limit=1).
The FDA announced on Jan. 19, 2018, that Terumo Cardiovascular Systems Corporation voluntarily recalled seven Flowmeter Modules due to inaccurate flow readings. The agency classified the recall as Class II.
How to tell if you have it
Brand: Terumo
Product: Flowmeter Module (accessory to Terumo Advanced Perfusion System 1)
Catalog #: 802018
Serial numbers: 01662, 01672, 01680, 01681, 01682, 01683, and 01687
UDI: 00886799000687
The hazard
According to the FDA, the recalled modules may provide inaccurate flow readings. The agency noted that depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Recent brand recalls include a May 28, 2025 recall of the Terumo CDI OneView BPM Probe for temperature inaccuracy risk and a March 3, 2025 recall of the Terumo CDI OneView Hematocrit Probe for dashed SO2 values. Other recent recalls of similar products include a Feb. 20, 2024 recall of Terumo Cardiovascular Procedure Kits with high crack check valve risk (Feb. 20, 2024), an Aug. 7, 2026 Philips EPIQ Elite Ultrasound System recall for inaccurate blood flow measurements (Aug. 7, 2026), and a March 24, 2026 Medline Namic Preceptor Manifold recall for particulate risk in blood pressure transducers (March 24, 2026).
How to tell if you have this one
Check if your Flowmeter Module has a serial number starting with 01662, 01672, 01680, 01681, 01682, 01683, or 01687. These units were sold with the Terumo Advanced Perfusion System 1.
Brand
Terumo
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify your Flowmeter Module's serial number to see if it matches the affected numbers: 01662, 01672, 01680, 01681, 01682, 01683, or 01687.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Kentucky, Michigan.
Recall timeline
FDA terminated this recall 6 months 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-1478-2018 (January 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1478-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.