Class IIOngoingZ-0966-2025
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Silicone
Lack of 510(k) clearance.
Adept Medical LtdJan 29, 2025
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 601–612 of 620 recalls
Class IIOngoingZ-0965-2025
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Double - Silicone
Lack of 510(k) clearance.
Adept Medical LtdJan 29, 2025
Class IIOngoingZ-0964-2025
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Double - Silicone
Lack of 510(k) clearance.
Adept Medical LtdJan 29, 2025
Class IIOngoingZ-0963-2025
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Silicone
Lack of 510(k) clearance.
Adept Medical LtdJan 29, 2025
Class IICompletedZ-0956-2025
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast.…
Murata Vios, Inc.MNJan 22, 2025
Class IIOngoingZ-0924-2025
Intuitive Surgical, Inc. recalls 8MM
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Intuitive Surgical, In…CAJan 22, 2025
Class IIOngoingZ-0923-2025
Intuitive Surgical, Inc. recalls 8MM
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Intuitive Surgical, In…CAJan 22, 2025
Class IIOngoingZ-0902-2025
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Sli…
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
QUIDEL ORTHONYJan 22, 2025
Class IIOngoingZ-0901-2025
QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Sli…
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
QUIDEL ORTHONYJan 22, 2025
Class IIOngoingZ-0846-2025
Tornier S.A.S. recalls Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surge…
Tornier S.A.S.Jan 22, 2025
Class IICompletedZ-0843-2025
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Augustine Temperature…MNJan 22, 2025
Class IICompletedZ-0842-2025
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Augustine Temperature…MNJan 22, 2025