Recall Register

Hamilton Medical, Inc.: FDA recalls

FDA enforcement reports name Hamilton Medical, Inc. as the recalling firm in 10 events. The events have 20 product records. The recalls started from 2012 to 2023. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

10 events, newest first.

FDA enforcement events of Hamilton Medical, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
26 Jul 2023Hamilton-C1, REF: 161001, Portable Intensive Care VentilatorDeviceClass I6Ongoing
15 Jun 2023HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonatesDeviceClass I4Ongoing
20 Jun 2017Intellicuff 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.DeviceClass II1Ongoing
26 Sep 2016Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients…DeviceClass II1Terminated
9 Mar 2016Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and…DeviceClass II1Terminated
1 Jun 2015Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.DeviceClass II3Terminated
24 Mar 2015Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.DeviceClass II1Terminated
22 Apr 2014HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patientsDeviceClass I1Terminated
26 Sep 2013HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its…DeviceClass II1Terminated
19 Dec 2012HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatricsDeviceClass I1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Hamilton Medical, Inc.: events for each product type
TypeEvents
Device10
Hamilton Medical, Inc.: events in each class
ClassEvents
Class II6
Class I4
Share of the events of the firm in Class I
40%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Hamilton Medical, Inc., by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Hamilton Medical, Inc.: FDA recalls. https://recallregister.com/firm/hamilton-medical-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NV

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Hamilton Medical, Inc. have?
Class II: 6 events. Class I: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Hamilton Medical, Inc.?
FDA event 92873, which the firm started on 26 Jul 2023. The first product in the record is: Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
How many FDA recalls of Hamilton Medical, Inc. have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.