FDA recall record · openFDA

Hamilton Medical AG

4 FDA recalls on record (2023–2025) — 4 device. 4 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/ 1

Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. 1

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the 1

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hy 1

Recalls

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H Class I 2025-06-26 Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended t Class I 2025-06-03 Ventilator HAMILTON-C6, PN: 160021 Class I 2024-05-15 HAMILTON-C6, REF: 160021 Class II 2023-03-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown