Vyaire Medical recalls enFlow Disposable Cartridges for intravenous warming therapy due to aluminum elution during fluid warming. Affected units distributed through March 7, 2019.
“Vyaire enFlow Disposable Cartridge Recall: Aluminum Elution Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68844-vyaire-enflow-disposable-cartridge-recall-aluminum-elution-risk. Based on FDA recall #Z-1385-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2019%22&limit=1).
The FDA announced on March 13, 2019, that Vyaire Medical voluntarily recalled the enFlow Disposable Cartridge due to aluminum elution during fluid warming. The agency issued recall number Z-1385-2019 for the Class I device.
How to tell if you have it
Brand: Vyaire Medical
Product: enFlow Disposable Cartridge
Part Number: 980200EU
Distribution: Worldwide, including US, Brazil, Canada, and others through March 7, 2019
Quantity: 5,782,820 units
The hazard
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Vyaire Medical has 9 other recalls on record since July 18, 2017. Other recent recalls of similar products include AirLife Infant Heated Wire Circuit Recall (April 10, 2025), Vyaire AirLife Resuscitator Recall (Jan. 10, 2024), and Vyaire Flexible Patient Circuit 3100A (Oct. 27, 2023). Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and Philips Integris-Allura System Recall (April 28, 2026).
How to tell if you have this one
The enFlow Disposable Cartridge has part number 980200EU. All units distributed through March 7, 2019 are affected.
Brand
Vyaire Medical
Category
Medical device
FDA recall event · 2 products
All 2 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 I
Status
Terminated
Distribution
Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam.
Recall number
Product, codes & lots
Z-1385-2019
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.; Part Number: 980200EU. All units distributed through March 7, 2019.
Z-1386-2019
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.; Part Number: 980202EU. All units distributed through March 7, 2019.
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the enFlow Disposable Cartridge for intravenous warming therapy if you have it.
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, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru,…” 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 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1385-2019 (March 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1385-2019 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.