FDA Medical Device Recalls (openFDA)
Hamilton Medical, Inc.: 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.
- Recall number
- Z-0335-2018
- Recalling firm
- Hamilton Medical, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2017-06-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
- Root cause
- Component design/selection
- Action
- Hamilton Medical sent a Recall Notice dated June 20, 2017, notifying them of the device correction. Consignees were informed that a Hamilton Representative would be in contact with them regarding the return of any devices. For further questions, please call (775) 858-3200.
- Quantity
- 176 units
- Distribution
- US Distribution to IL and TX.
- Lot, serial or model codes
- Serial No. 1000 thru 2090; P/N 951001
- 510(k) numbers
- ["K150893"]
- PMA numbers
- not on file
- Product code
- BSK
- Firm FEI
- 2937708
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28