Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA FoodHerbsForever- Gastro Care; Ayruvedic Herbal Supplement; 90 VEGE Capsules; Extract 800 MG each capsule. UPC: 8 07814 00124 3
HerbsForever- Gastro Care; Ayruvedic Herbal Supplement; 90 VEGE Capsules; Extract 800 MG each capsule. UPC: 8 07814 00124 3
Potential undeclared allergen ingredient (Wheat)
FDA DevicesAllura Xper FD20/20; Model Number: 722038;
Allura Xper FD20/20; Model Number: 722038;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesAllura Xper FD20 Biplane; Model Number: 722013;
Allura Xper FD20 Biplane; Model Number: 722013;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FDA DrugsAdvil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesAllura Xper FD10; Model Number: 722010;
Allura Xper FD10; Model Number: 722010;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA FoodFrosted Almond; 20 lbs (bulk); No UPC# Bulk Product Code: 23208
Frosted Almond; 20 lbs (bulk); No UPC# Bulk Product Code: 23208
elevated levels of aflatoxin
FDA FoodHealthy Truth brand Moringa Powder; 5lb and 20lb
Healthy Truth brand Moringa Powder; 5lb and 20lb
Products may be contaminated with Salmonella Richmond.
FDA DevicesAllura Xper FD10; Model Number: 722003;
Allura Xper FD10; Model Number: 722003;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DrugsLanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Presence of Particulate Matter.
FDA FoodJumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
elevated levels of chloramphenicol in frozen shrimp
FDA DrugsLUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA DrugsBayer 2Pk- 25 CT
Bayer 2Pk- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsClaritin, 20 Count, UPC: 655708016305
Claritin, 20 Count, UPC: 655708016305
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
NHTSANissan North America, Inc. - Improperly Welded Door Strikers/FMVSS 206
Nissan North America, Inc. - Improperly Welded Door Strikers/FMVSS 206
A door that opens unexpectedly while the vehicle is in motion increases the risk of injury or a crash.
FDA DevicesMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA DrugsBenadryl, 25'S 2PK Box, UPC 815556020316
Benadryl, 25'S 2PK Box, UPC 815556020316
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsTYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsLIQUID DAYQUIL 12/8oz
LIQUID DAYQUIL 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsEXCEDRIN MIGRAINE 2'S- 25 CT
EXCEDRIN MIGRAINE 2'S- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesAllura Xper FD10F; Model Number: 722002;
Allura Xper FD10F; Model Number: 722002;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesBrand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.