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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
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 is used to deliver fr... Class I Hamilton Medical AG
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 separating process. This... Class I Hamilton Medical AG
May 15, 2024 Ventilator HAMILTON-C6, PN: 160021 Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnec... Class I Hamilton Medical AG
Mar 14, 2023 HAMILTON-C6, REF: 160021 Software error causes, safety ventilation, in which ventilation continues in the "safety ventilat... Class II Hamilton Medical AG
Sep 22, 2022 Hamilton-C6 Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for... Class II Hamilton Medical AG
Jun 27, 2022 HAMILTON-C6 Intensive Care Ventilator, REF: 160021 Ventilator status indicator board can become loose, which could lead to water ingress (disinfecta... Class I Hamilton Medical AG
Jan 5, 2021 HAMILTON-H900 Humidifier, Models: 950001, 950004 When starting a humidifier, intended for respiratory gas conditioning during invasive and noninva... Class III Hamilton Medical AG
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 ventilator entering ... Class I Hamilton Medical AG
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 battery charge than what... Class II Hamilton Medical AG
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 battery charge than what... Class II Hamilton Medical AG
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 ventilator to open the inspi... Class II Hamilton Medical AG
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 ventilator to open the inspi... Class II Hamilton Medical AG
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.