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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
Devices are not suitable for organ transplant.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Product testing did not meet expected stability criteria.
Safety and efficacy of dialysis acid concentrate cannot be assured
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.