🏥 Medical Devices • 15,809 recalls
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Ossur Americas
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Medline Industries
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
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.