Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
All Recalls
95,114 total recalls in our database
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
Combat Medical Systems
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Combat Medical Systems
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Becton Dickinson & Company
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
Northern Tool & Equipment Powerhorse 13000ES Portable Generators
Unknown Manufacturer
The portable generators have a wiring error which can result in an electrical shock to users.
Potter Electric Addressable Pull Stations Single/Dual Action
Potter Electric Signal Company, LLC, of St. Louis, Mo.
The pull handle on some units can fail to activate the fire alarm system when manually pulled, posing a risk of failure to alert consumers to a fire.
Bee Free Children's Helmets
Shenzhen Haochen Industrial Co. Ltd., of China
The recalled helmets were incorrectly advertised and marketed for children aged 2 years or older. However, the recalled helmets do not comply with minimum safety requirements for children younger than 5 and pose a risk of head injury to those children.
Margo Taper Candle Holders
Unknown Manufacturer
The candle holders can catch on fire if they come in contact with the candle's flame, posing a fire hazard.
think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack with UPC 753656712338
Glanbia Performance Nutrition (Manufacturing)
Undeclared ingredients including but not limited to pecans and almonds
Undeclared Soy
Butternut Veggie Spirals Tray, 10oz, Keep Refrigerated
Pero Family Farms Company
Butternut Squash products potentially contaminated with Listeria monocytogenes.
Butternut Squash Bag, 5 lbs
Pero Family Farms Company
Butternut Squash products potentially contaminated with Listeria monocytogenes.