The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
All Recalls
95,025 total recalls in our database
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Chromsystems Instruments & Chemicals GmbH
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
Olympus Corporation of the Americas
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Missing solder battery connection, which could interrupt power of insulin pump.
Due to a change in handle material and process, probe handle may crack.
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Olympus Corporation of the Americas
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
CRAFTSMAN® CMECSP610 10-inch corded chain saws with extension poles
Unknown Manufacturer
The chain saw can start unexpectedly without operation of the switch when the extension cord adaptor is connected upside down, posing a laceration hazard.
Dash® X FM child bicycle seats
Unknown Manufacturer
The reclining plate that holds the child bicycle seat in place can detach, making the child seat unstable and can cause the rider of the bicycle to lose control, posing a crash hazard.
Fiskars 16 foot Extendable Pole Saw/Pruners
Unknown Manufacturer
The telescoping poles of the pole saw/pruner can separate, causing the poles to come apart and fall down and the saw blade and pruner head to drop, posing a laceration hazard.
Yeti 25A Fast Charge Power Supplies
Unknown Manufacturer
The connection between the power supply module and the output cord can be loose, causing the electrical connections to overheat, posing a fire hazard.
Su-VGun and GrillGun propane torch guns
Unknown Manufacturer
Propane gas can leak from the GrillBlazer torch, posing a fire hazard to consumers.
allen + roth 62-inch Electric Fireplaces
Easy Top Enterprises LTD, of China
Wiring connectors in the fireplace can overheat, posing a fire hazard.
Delta UV EA-4H-10 ultra-violet generators installed in swimming pools and swim spas
Neptune Benson, of Warwick, Rhode Island (after August 2016)
Water can leak within the generator, causing excessive heat build-up in the area where the power cord connects to the body of the generator unit, which can pose a fire hazard.
Children's flashlights
Unknown Manufacturer
The batteries in the flashlight can overheat, posing burn and fire hazards.
Western Chief toddler light-up rain boots
Washington Shoe Company, of Kent, Wash.
Rivets used to attach the handles to the boot can detach, posing a choking hazard to children.