All recalls7,819 total
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.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
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.
foreign objects (black plastic planting film) in granulated onion powder
Clostridium botulinum (uneviscerated fish)
100% Appleberry Juice contaminated with cleaning solution, Peracetic Acid.
Undeclared sulfites.
Defective container - seal not adhering to bottles
Product testing did not meet expected stability criteria.
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
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.
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Product tested positive for Salmonella.
Undeclared sulfites
Unapproved color (carmoisine).
Unapproved color (carmoisine).
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.
Undeclared Milk and FD&C Blue #1.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.