All recalls8,504 total
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
Undeclared allergen (fish). Anthony's Barbecue & Dip-It Sauce label does not declare Worcestershire (Anchovy).
Defective Container - A defect in the side-seal which allows leakage of product.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
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.
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
foreign objects (black plastic planting material) in granulated onion
foreign objects (black plastic planting material) in granulated onion
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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.