Lower riskMedical device recall · FDA · Published April 18, 2019
Terumo EPGS Gas System Recall: Inaccurate Gas Flow Rate Risk
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog # 801188) due to potential inaccurate gas flow rates, which could affect patient safety during medical procedures.
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
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Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586
✎ GovInfoNow plain-language explainer
Terumo is recalling its Advanced Perfusion System 1 Electronic Patient Gas System because a defect in the internal flowmeter may cause inaccurate gas flow rates. This could lead to improper oxygen delivery to patients during surgery, posing a risk to patient safety. Read more at govinfonow.com/recall/68203-terumo-epgs-gas-system-recall-inaccurate-gas-flow-rate-risk.
“Terumo EPGS Gas System Recall: Inaccurate Gas Flow Rate Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68203-terumo-epgs-gas-system-recall-inaccurate-gas-flow-rate-risk. Based on FDA recall #Z-1337-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2019%22&limit=1).
The FDA announced on April 18, 2019, that Terumo Cardiovascular Systems Corporation voluntarily recalled its Terumo Advanced Perfusion System 1 Electronic Patient Gas System due to a potential inaccuracy in gas flow rate output. The agency issued recall number Z-1337-2019 for the Class II device.
How to tell if you have it
Brand: Terumo
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System
Catalog #: 801188
UDI: 00886799000588
The hazard
The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. The hazard stems from a defect in the internal flowmeter that may cause the gas flow rate output to be inaccurate.
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 EPIQ Elite Ultrasound System Recall (August 7, 2026), Laborie Solar GI System Recall (May 21, 2026), and Olympus UHI-2 Insufflation Unit Recall (January 16, 2026).
How to tell if you have this one
Check for the product name 'Terumo Advanced Perfusion System 1 Electronic Patient Gas System' with catalog number 801188 and unique device identifier 00886799000588.
Brand
Terumo
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number 801188 and unique device identifier 00886799000588 on the product label.
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) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.” 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 13 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-1337-2019 (April 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1337-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.