Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DrugsQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DrugsMemantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Failed Dissolution Specifications
FDA DevicesBrand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
FDA Drugs0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Lack of Assurance of Sterility
FDA Drugsexchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DevicesBrand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
FDA DevicesB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
NHTSAWinnebago Industries, Inc. - Park Outside: Generator May Turn On Without Operator Action
Winnebago Industries, Inc. - Park Outside: Generator May Turn On Without Operator Action
People in an enclosed space, such as a garage, with a running generator may be at an increased risk of injury or death from carbon monoxide poisoning.
FDA DevicesiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
NHTSAHyundai Motor America - Misassembled Air Bag Sensors
Hyundai Motor America - Misassembled Air Bag Sensors
Air bags that do not deploy as intended increase the risk of injury in a crash.
NHTSAHexagon Purus Systems USA LLC - Digital Display May Show Incorrect Air Brake Pressure/FMVSS 121
Hexagon Purus Systems USA LLC - Digital Display May Show Incorrect Air Brake Pressure/FMVSS 121
A display that does not show accurate information may fail to alert the driver to an actual brake issue, increasing the risk of a crash.
NHTSAQ'Straint - Wheelchair Restraint Retractor May Not Lock
Q'Straint - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
NHTSAMitsubishi Motors North America, Inc. - Liftgate Gas Springs May Rupture
Mitsubishi Motors North America, Inc. - Liftgate Gas Springs May Rupture
A gas spring cylinder rupture or a liftgate falling unexpectedly can increase the risk of injury.
NHTSAForest River, Inc. - Contact with Fender May Damage Tire
Forest River, Inc. - Contact with Fender May Damage Tire
A damaged tire may cause a loss of vehicle control, increasing the risk of a crash.
NHTSADaimler Trucks North America, LLC - Driver Seat Belt Anchor Improperly Installed/FMVSS 210
Daimler Trucks North America, LLC - Driver Seat Belt Anchor Improperly Installed/FMVSS 210
An improperly installed seat belt anchor may fail to properly restrain the driver in a crash, increasing the risk of injury.
NHTSADaimler Trucks North America, LLC - Driver Seat Belt Anchor Improperly Installed/FMVSS 210
Daimler Trucks North America, LLC - Driver Seat Belt Anchor Improperly Installed/FMVSS 210
An improperly installed seat belt anchor may fail to properly restrain the driver in a crash, increasing the risk of injury.
NHTSAGoodyear Tire & Rubber Company - Tire Tread May Separate
Goodyear Tire & Rubber Company - Tire Tread May Separate
Tread separation increases the risk of a crash.
NHTSABlue Bird Body Company - Improperly Tightened Windshield Wiper Blade Assemblies
Blue Bird Body Company - Improperly Tightened Windshield Wiper Blade Assemblies
Loose fasteners may cause the windshield wipers to become inoperative, reducing visibility and increasing the risk of a crash.
NHTSAJaguar Land Rover North America, LLC - Loss of Drive Power from DC-DC Converter Failure
Jaguar Land Rover North America, LLC - Loss of Drive Power from DC-DC Converter Failure
A loss of drive power increases the risk of a crash.
NHTSAAltec Industries, Inc. - Improperly Installed Front End Radar
Altec Industries, Inc. - Improperly Installed Front End Radar
While driving, the brakes may activate unexpectedly without the driver's input, increasing the risk of a crash.
NHTSABlue Bird Body Company - Improperly Tightened Windshield Wiper Blade Assemblies
Blue Bird Body Company - Improperly Tightened Windshield Wiper Blade Assemblies
Loose fasteners may cause the windshield wipers to become inoperative, reducing visibility and increasing the risk of a crash.
NHTSAAltec Industries, Inc. - Inoperative Emergency Stop Switch
Altec Industries, Inc. - Inoperative Emergency Stop Switch
An inoperative emergency stop switch increases the risk of injury.
CPSCFun and Function Recalls Children's Metal Multi-Point Swing Frames Due to Risk of Injury from Fall Hazard
Fun and Function Recalls Children's Metal Multi-Point Swing Frames Due to Risk of Injury from Fall Hazard
The swing frames can crack or break during use, posing a fall hazard, which can result in injury.
CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.