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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 19 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2023 Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
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 leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-MR1, REF: 161010, Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
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 leak electrolyte ont... Class I Hamilton Medical, Inc.
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 ventilator may stop ... Class I Hamilton Medical, Inc.
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 ventilator may stop ... Class I Hamilton Medical, Inc.
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 ventilator may stop ... Class I Hamilton Medical, Inc.
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 ventilator may stop ... Class I Hamilton Medical, Inc.
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, motor may cease to... Class II Hamilton Medical, Inc.
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 become loose during ... Class II Hamilton Medical, Inc.
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, suctioning , and r... Class II Hamilton Medical, Inc.
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, single use. When a ven... Class II Hamilton Medical, Inc.
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, single use. When a ven... Class II Hamilton Medical, Inc.
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, single use. When a ven... Class II Hamilton Medical, Inc.
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 continues but the informatio... Class II Hamilton Medical, Inc.
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 unintentionally after the ac... Class I Hamilton Medical, Inc.
Sep 26, 2013 HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonad... Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm syst... Class II Hamilton Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.