FDA Device recall Z-0335-2018
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tu…
- FDA Device
- Class II
- ongoing
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tu… by Hamilton Medical, citing issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0335-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-06-20 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hamilton Medical |
| Distribution | IL, TX |
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.
Reason
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Identifiers
| code_info | Serial No. 1000 thru 2090; P/N 951001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0335-2018%22
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