Intellicuff Standalone — Class II medical device recall Z-0335-2018
Ongoing recall by Hamilton Medical, Inc., reported 2018-01-24, distributed in IL, TX. Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
| Recall number | Z-0335-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical, Inc., Reno, NV, United States |
| Recall initiated | 2017-06-20 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-24 |
| Distributed | IL, TX |
| Quantity | 176 units |
| Serial numbers | 1000 |
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 for recall
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
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-0335-2018. 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.