Recall Register

Food, drugs, devices › Firms

Hamilton Medical AG

FDA recalling firm · 12 enforcement events · 14 product records · 2018–2026 · N/A

Hamilton Medical AG has 12 FDA enforcement events on this register (14 product records) between 2018 and 2026: 12 device; the busiest year was 2018 with 2.

50% of its events are Class I; the most common class is Class I (6). 9 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Device12
Class I6
Class II5
Class III1

Class I: 50% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for Hamilton Medical AG by year initiated.

Questions and answers

How many FDA recalls has Hamilton Medical AG had?

12 enforcement events (14 product records) on this register, 2018–2026: 12 device.

Are any Hamilton Medical AG recalls ongoing?

9 events are listed as ongoing in the current openFDA export.

What class are Hamilton Medical AG recalls?

6 Class I, 5 Class II, 1 Class III. 50% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.