95,018 total recalls in our database
King Systems Corp.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
King Systems Corp.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
King Systems Corp.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Unknown Manufacturer
The metal straw inside the tumbler can cut your mouth and/or fingers, posing a laceration hazard.
Unknown Manufacturer
The sprayer pump on the backpack can leak chemicals into the battery compartment and can cause the battery to overheat, posing a fire hazard.
Unknown Manufacturer
The lithium battery in the recalled Charge Case Accessory can overheat, posing a fire hazard.
Unknown Manufacturer
When attached to drywall without toggle bolts, the panels of the recalled floating wall theater can detach and fall, posing an injury hazard to consumers. When the bottom panel is attached to any wall surface without installing the safety screw that is included with the product, the bottom panel of the recalled floating wall theater can detach and fall, posing an injury hazard to consumers.
Polaris Industries Inc., of Medina, Minnesota
The high voltage cables on the motor controller unit can be loose, causing the cable to arc or overheat while in use, posing fire and crash hazards and risk of serious injury.
Unknown Manufacturer
The gates violate the federal safety regulations for expansion gates and expandable enclosures. A child's torso can fit through the opening between the gate slat and side wall, posing an entrapment hazard to children.
Quantum Fulfillment and Support
Undeclared Fish Allergen
Incomplete pasteurization
Potential undeclared gluten product is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.