🏥 Medical Devices Class I - Dangerous
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
All Recalls
92,900 total recalls in our database
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
King Systems Corp.
🏥 Medical Devices Class I - Dangerous
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.
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
King Systems Corp.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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 LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
King Systems Corp.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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 LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
King Systems Corp.
🏥 Medical Devices Class I - Dangerous
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.
Tumblers with a Metal Straw
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The metal straw inside the tumbler can cut your mouth and/or fingers, posing a laceration hazard.
Bauer 20V Battery-Powered 4-Gallon Backpack Sprayers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The sprayer pump on the backpack can leak chemicals into the battery compartment and can cause the battery to overheat, posing a fire hazard.
Humane Charge Case Accessory for Ai Pin
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The lithium battery in the recalled Charge Case Accessory can overheat, posing a fire hazard.
Manhattan Comfort Floating Wall Theater Entertainment Centers and Panels
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
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.
Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
Polaris Industries Inc., of Medina, Minnesota
🏠 Consumer Products Class I - Dangerous
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.
Vevor Baby Gates
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
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.
Collagen Joint Support with Black Currant LOT#: Q241851; 14 Stick Pack 3.92 oz
Quantum Fulfillment and Support
🍎 Food Class I - Dangerous
Undeclared Fish Allergen