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Hamilton Medical AG FDA Recalls
9 recalls on file across devices, 5 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 Class IMay 29, 2026Ventilator coaxial breathing circuit may have, expiratory va |
| IntelliCuff, Portable automatic cuff pressure controller REF: 951001Class IIMay 22, 2026Due to reported complaints, the cuff device may alarm with a |
| Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HClass IJun 26, 2025Ventilator coaxial breathing circuit may have a crack in blu |
| Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended tClass IJun 3, 2025A mechanical defect on a printed circuit board (PCB) as a re |
| Ventilator HAMILTON-C6, PN: 160021Class IMay 15, 2024Ventilator may enter sensor fail mode, ventilation may not r |
| HAMILTON-C6, REF: 160021Class IIMar 14, 2023Software error causes, safety ventilation, in which ventilat |
| Hamilton-C6Class IISep 22, 2022Due to a malfunction related to the backlight on the ventila |
| HAMILTON-C6 Intensive Care Ventilator, REF: 160021Class IJun 27, 2022Ventilator status indicator board can become loose, which co |
| HAMILTON-H900 Humidifier, Models: 950001, 950004Class IIIJan 5, 2021When starting a humidifier, intended for respiratory gas con |