The Tri-Flo Subglottic Suction System — Class I medical device recall Z-2826-2018
Terminated recall by Vyaire Medical, reported 2018-08-29, distributed in AZ, CA, CT, FL, GA, IA, IL, IN…. Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Sucti
| Recall number | Z-2826-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2018-06-20 |
| Classified | 2018-08-21 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-07-28 |
| Distributed | AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI |
| Quantity | 2,150 units |
| Reason classes | foreign material, device malfunction |
| Serial numbers | 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256 |
| Model numbers | CM28010 |
Product
The Tri-Flo Subglottic Suction System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2826-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.