Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 28 recalls
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Due to required inspections not being performed on products/units that have gone through servicing.
Due to required inspections not being performed on products/units that have gone through servicing.
Due to required inspections not being performed on products/units that have gone through servicing.
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on pat…
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.