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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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