Class II — Hamilton Medical, Inc.
| Recalling firm | HAMILTON MEDICAL, INC. |
|---|---|
| Registered facility | HAMILTON MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| Product | Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates. |
| Quantity | 176 units |
| Distribution | US Distribution to IL and TX. |
| Initiated | 2017-06-20 |
| Classified | 2018-01-12 |
| Recall number | Z-0335-2018 |
| 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 II recall — Hamilton Medical, Inc. (Z-0335-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77617/
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