Class I — Avanos Medical, Inc.
| Recalling firm | Avanos Medical, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation. |
| Product | BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. |
| Quantity | 220 units |
| Distribution | US Nationwide distribution in the state of Oklahoma. |
| Initiated | 2023-02-03 |
| Classified | 2023-03-13 |
| Terminated | 2024-09-05 |
| Recall number | Z-1190-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Avanos Medical, Inc. (Z-1190-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91663/
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