Hamilton Medical, Inc.

Complete recall history across all FDA and CPSC categories — 19 total recalls

Hamilton Medical, Inc. 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 (19)

FDA medical device enforcement actions by Hamilton Medical, Inc.

Date Product Reason Class
Jul 26, 2023 Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jul 26, 2023 Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jul 26, 2023 Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jul 26, 2023 Hamilton-MR1, REF: 161010, Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jul 26, 2023 Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jul 26, 2023 Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator Degrading capacitors on the control board of ventilators and spare parts may ... Class I
Jun 15, 2023 HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positi... Due to a software anomaly after approximately 91 days of cumulative use, the ... Class I
Jun 15, 2023 HAMILTON C2 Ventilator Is intended to provide positive pressure ventilator... Due to a software anomaly after approximately 91 days of cumulative use, the ... Class I
Jun 15, 2023 HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended t... Due to a software anomaly after approximately 91 days of cumulative use, the ... Class I
Jun 15, 2023 HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressur... Due to a software anomaly after approximately 91 days of cumulative use, the ... Class I
Jun 20, 2017 Intellicuff Standalone (PN 951001) Used to continuously measure and automa... Issue related to the performance of the motor in recalled product. During use... Class II
Sep 26, 2016 Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is int... Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially ... Class II
Mar 9, 2016 Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog numbe... After performing the suctioning maneuver, including disconnecting the patient... Class II
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179.... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, si... Class II
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, si... Class II
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177.... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, si... Class II
Mar 24, 2015 Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers fo... Customer reports that the ventilator display can freeze. Ventilation continue... Class II
Apr 22, 2014 HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anes... Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintent... Class I
Sep 26, 2013 HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonad... Manufacturer defined limits for improperly functioning loudspeakers of the HA... 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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