Hamilton Medical AG
FDA Regulatory Profile
Hamilton Medical AG appears in FDA public data with 34 recalls — including 18 Class I (most serious) —, 45 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2463-2026, Class I) was initiated on May 29, 2026. Its most recent 510(k) clearance was granted on February 5, 2021.
Summary
- Total Recalls
- 34 (18 Class I)
- 510(k) Clearances
- 45
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2463-2026 | Class I | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON- | May 29, 2026 |
| Z-2625-2026 | Class II | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | May 22, 2026 |
| Z-2167-2025 | Class I | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used | June 26, 2025 |
| Z-2328-2025 | Class I | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a v | June 3, 2025 |
| Z-2020-2024 | Class I | Ventilator HAMILTON-C6, PN: 160021 | May 15, 2024 |
| Z-2526-2023 | Class I | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator | July 26, 2023 |
| Z-2529-2023 | Class I | Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator | July 26, 2023 |
| Z-2530-2023 | Class I | Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator | July 26, 2023 |
| Z-2527-2023 | Class I | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator | July 26, 2023 |
| Z-2528-2023 | Class I | Hamilton-MR1, REF: 161010, Intensive Care Ventilator | July 26, 2023 |
| Z-2525-2023 | Class I | Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator | July 26, 2023 |
| Z-2142-2023 | Class I | HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support t | June 15, 2023 |
| Z-2139-2023 | Class I | HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory | June 15, 2023 |
| Z-2140-2023 | Class I | HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pres | June 15, 2023 |
| Z-2141-2023 | Class I | HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and | June 15, 2023 |
| Z-1429-2023 | Class II | HAMILTON-C6, REF: 160021 | March 14, 2023 |
| Z-0267-2023 | Class II | Hamilton-C6 | September 22, 2022 |
| Z-1525-2022 | Class I | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | June 27, 2022 |
| Z-1385-2022 | Class III | HAMILTON-H900 Humidifier, Models: 950001, 950004 | January 5, 2021 |
| Z-1874-2019 | Class I | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are | March 25, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201306 | HAMILTON-C3 | February 5, 2021 |
| K201658 | Hamilton-C6 | December 11, 2020 |
| K193228 | Hamilton-G5 | May 4, 2020 |
| K181216 | HAMILTON-T1, HAMILTON-C1 | August 2, 2019 |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | September 20, 2017 |
| K161450 | HAMILTON-C3 | April 27, 2017 |
| K153046 | HAMILTON-MR1 | September 6, 2016 |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | May 3, 2016 |
| K150893 | IntelliCuff | January 29, 2016 |
| K140939 | HAMILTON-T1,HAMILTON-C1 | September 2, 2015 |
| K122438 | HAMILTON-MR1 | November 20, 2013 |
| K131774 | HAMILTON-G5 | October 9, 2013 |
| K123637 | HAMILTON-C3 | December 21, 2012 |
| K121225 | HAMILTON-C2 | November 16, 2012 |
| K120574 | HAMILTON-C1 | May 30, 2012 |
| K120670 | HAMILTON-T1 | April 3, 2012 |
| K112006 | HAMILTON-TC1 | February 9, 2012 |
| K103803 | HAMILTON-G5 | November 23, 2011 |
| K102775 | HAMILTON-C2 | January 21, 2011 |
| K092148 | HAMILTON-C2 | March 4, 2010 |