370 recalls tagged with “nhtsa regulated”.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Ferno-Washington Inc. recalled 138 Power X2 powered ambulance cots nationwide. The recall is due to fastening post hardware that could loosen and detach. Stop using the device and contact Ferno-Washington for instructions.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Potential for compromised integrity of the sterile packaging.
cGMP deviations: Temperature excursion during transportation.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Potential contamination with heavy metal (Lead).