🏥 Medical Devices Class I - Dangerous
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.
All Recalls
95,114 total recalls in our database
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Labeling error, incorrect expiration date.
🏥 Medical Devices Class I - Dangerous
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Bausch & Lomb Surgical
🏥 Medical Devices Class I - Dangerous
Product may be missing toric axis marks.
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Missing solder battery connection, which could interrupt power of insulin pump.
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
🏥 Medical Devices Class I - Dangerous
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.
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
🏥 Medical Devices Class I - Dangerous
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
🏥 Medical Devices Class I - Dangerous
Missing solder battery connection, which could interrupt power of insulin pump.
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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.