Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Foreign object
Undeclared FD&C Red #40
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.
Contaminated with Clostridium botulinum
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
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.
Defective Container - A defect in the side-seal which allows leakage of product.
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
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.
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.
foreign objects (black plastic planting material) in granulated onion