🏥 Medical Devices • 15,203 recalls
Orchestrate Orthodontic Technologies
Due to product label/labeling being altered from it's approved state.
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Wright Medical Technology
The package contents and package labeling do not match.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
DRG International
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Howmedica Osteonics
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Beeken Biomedical
Endotoxin levels exceeded allowable limits.
Howmedica Osteonics
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Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Thoratec
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
Boston Scientific
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Wright Medical Technology
The package contents and package labeling do not match.