Hamilton Medical AG
Complete recall history across all FDA and CPSC categories — 12 total recalls
Hamilton Medical AG appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (12)
FDA medical device enforcement actions by Hamilton Medical AG
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 26, 2025 | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve... | Ventilator coaxial breathing circuit may have a crack in blue tubing, which i... | Class I |
| Jun 3, 2025 | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021Z... | A mechanical defect on a printed circuit board (PCB) as a result of PCB separ... | Class I |
| May 15, 2024 | Ventilator HAMILTON-C6, PN: 160021 | Ventilator may enter sensor fail mode, ventilation may not re-initiate, after... | Class I |
| Mar 14, 2023 | HAMILTON-C6, REF: 160021 | Software error causes, safety ventilation, in which ventilation continues in ... | Class II |
| Sep 22, 2022 | Hamilton-C6 | Due to a malfunction related to the backlight on the ventilator screen. The s... | Class II |
| Jun 27, 2022 | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | Ventilator status indicator board can become loose, which could lead to water... | Class I |
| Jan 5, 2021 | HAMILTON-H900 Humidifier, Models: 950001, 950004 | When starting a humidifier, intended for respiratory gas conditioning during ... | Class III |
| Mar 25, 2019 | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTO... | New software version for affected ventilators reduces the probability of the ... | Class I |
| Mar 12, 2018 | Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adul... | After two and a half years, the battery fuel gauge may indicate a higher batt... | Class II |
| Mar 12, 2018 | Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adul... | After two and a half years, the battery fuel gauge may indicate a higher batt... | Class II |
| Mar 9, 2018 | Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is ... | An out of specification component on the control board may cause the ventilat... | Class II |
| Mar 9, 2018 | Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is ... | An out of specification component on the control board may cause the ventilat... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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