Recall Register

Hamilton Medical AG: FDA recalls

FDA enforcement events from 2018 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Hamilton Medical AG as the recalling firm in 12 events. The events have 14 product records. The recalls started from 2018 to 2026. All the events are device recalls. By FDA enforcement events, Hamilton Medical AG is number 291 of 1,628 firms that have a page. Events that Hamilton Medical AG started: 1 in 2024 and 2 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class I is 50.0% of its events and 17.7% of all FDA events.

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

12 events, newest first.

FDA enforcement events of Hamilton Medical AG
InitiatedProduct (first record)TypeClassRecordsStatus
29 May 2026Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.DeviceClass I1Ongoing
22 May 2026IntelliCuff, Portable automatic cuff pressure controller REF: 951001DeviceClass II1Ongoing
26 Jun 2025Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.DeviceClass I1Ongoing
3 Jun 2025Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.DeviceClass I1Ongoing
15 May 2024Ventilator HAMILTON-C6, PN: 160021DeviceClass I1Ongoing
14 Mar 2023HAMILTON-C6, REF: 160021DeviceClass II1Ongoing
22 Sep 2022Hamilton-C6DeviceClass II1Ongoing
27 Jun 2022HAMILTON-C6 Intensive Care Ventilator, REF: 160021DeviceClass I1Ongoing
5 Jan 2021HAMILTON-H900 Humidifier, Models: 950001, 950004DeviceClass III1Completed
25 Mar 2019HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care…DeviceClass I1Terminated
12 Mar 2018Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.DeviceClass II2Ongoing
9 Mar 2018Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.DeviceClass II2Terminated

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 AG: events for each product type
TypeEvents
Device12
Hamilton Medical AG: events in each class
ClassEvents
Class I6
Class II5
Class III1
Share of the events of the firm in Class I
50%
Share of all events on the register in Class I
18%
Events with the status Ongoing
9

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 AG, by the year that the recall started. The largest year is 2018, with 2 events.

Official channels

Cite this page

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

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
N/A

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 rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Hamilton Medical AG have?
Class I: 6 events. Class II: 5 events. Class III: 1 event. 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 AG?
FDA event 99028, which the firm started on 29 May 2026. The first product in the record is: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
How many FDA recalls of Hamilton Medical AG have the status Ongoing?
9 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.