Use cautionMedical device recall · FDA · Published June 20, 2018
Vyaire Medical Tri-Flo Suction System Recall: Risk of Catheter Breaking Off
Vyaire Medical recalls Tri-Flo Subglottic Suction Systems with potential catheter break-off causing aspiration of foreign bodies. Affected units have specific part and serial numbers.
Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
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📍Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420
✎ GovInfoNow plain-language explainer
Vyaire Medical is recalling its Tri-Flo Subglottic Suction System due to a risk that the catheter tip could break off during use, potentially causing a foreign body to be inhaled by patients. This could lead to serious health complications if the broken piece enters the airway. Read more at govinfonow.com/recall/70827-vyaire-medical-tri-flo-suction-system-recall-risk-of-catheter.
“Vyaire Medical Tri-Flo Suction System Recall: Risk of Catheter Breaking Off.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70827-vyaire-medical-tri-flo-suction-system-recall-risk-of-catheter. Based on FDA recall #Z-2826-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2826-2018%22&limit=1).
The FDA announced on June 20, 2018, that Vyaire Medical is recalling The Tri-Flo Subglottic Suction System due to a potential patient safety risk. The distal soft tip may break off during use, leading to aspiration of a solid foreign body.
Vyaire Medical identified that the distal soft tip of the catheter has the potential to break off during patient use. This failure can result in the aspiration of a solid foreign body.
Context
GovInfoNow's records show Vyaire Medical has 9 other recalls on record since July 18, 2017. Other recent recalls include the AirLife Infant Heated Wire Circuit Recall (April 10, 2025) and the Vyaire AirLife Resuscitator Recall (January 10, 2024). Similar recent recalls of catheter products include the Medline Urethral Catheter Tray Recall (May 4, 2026) and the Medtronic Harmony Catheter System Recall (May 22, 2026).
How to tell if you have this one
Check for the part number CM28010 and serial numbers 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, or 0004008255, 0004008256 on the device or packaging.
Brand
Vyaire Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the part number CM28010 and serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 18 states.
Listed by the agency
Not listed
FDA distribution: “Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-2826-2018 (June 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2826-2018 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.