Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 121–132 of 3,846 recalls
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a…
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of p…
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled moti…