Class IOngoingZ-2183-2025
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1)
Laryngoscope handles may not illuminate as intended.
Flexicare Medical (Don…Aug 13, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 397–408 of 595 recalls
Class IOngoingZ-2182-2025
Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1)
Laryngoscope handles may not illuminate as intended.
Flexicare Medical (Don…Aug 13, 2025
Class IOngoingZ-2180-2025
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets REF: 10013186
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
CareFusion 303, Inc.CAAug 13, 2025
Class IOngoingZ-2179-2025
CareFusion 303, Inc. recalls BD Alaris Pump Module Model
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
CareFusion 303, Inc.CAAug 13, 2025
Class IOngoingZ-2176-2025
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV…
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent,…
B BRAUN MEDICAL INCPAAug 13, 2025
Class IOngoingZ-2129-2025
ICU Medical, Inc. recalls Plum Duo Infusion System
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
ICU Medical, Inc.ILAug 13, 2025
Class IOngoingZ-2167-2025
Hamilton Medical AG recalls Breathing circuit set
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreath…
Hamilton Medical AGAug 6, 2025
Class IOngoingZ-2164-2025
Abiomed, Inc. recalls Automated Impella Controller (AIC)
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Abiomed, Inc.MAAug 6, 2025
Class IOngoingZ-2161-2025
Draeger, Inc. recalls SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Draeger, Inc.PAAug 6, 2025
Class IOngoingZ-2160-2025
Draeger, Inc. recalls HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Draeger, Inc.PAAug 6, 2025
Class IOngoingZ-2159-2025
Draeger, Inc. recalls SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Draeger, Inc.PAAug 6, 2025
Class IOngoingZ-2158-2025
Draeger, Inc. recalls SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Draeger, Inc.PAAug 6, 2025