Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesMiniMed 620G Insulin Pump (MMT-1750)
MiniMed 620G Insulin Pump (MMT-1750)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA DeviceseTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesAllura Xper FD20/15 OR Table; System Code: 722059;
Allura Xper FD20/15 OR Table; System Code: 722059;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA FoodMEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124282
MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124282
Products contain cyclamates (banned sweetener)
FDA DeviceseTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA DevicesALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesAzurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA FoodMama Rose's Prickly Pear Salad Dressing. 12 oz (340 g) glass bottle with gold cap.
Mama Rose's Prickly Pear Salad Dressing. 12 oz (340 g) glass bottle with gold cap.
Undeclared sulfites.
FDA DevicesCardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
FDA DevicesAzurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA Food" Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable 5.7 oz 011110696953
" Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable 5.7 oz 011110696953
Foreign Object (Glass)
FDA DevicesALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
NHTSAToyota Motor Engineering & Manufacturing - Fuel Pump May Fail
Toyota Motor Engineering & Manufacturing - Fuel Pump May Fail
Fuel pump failure can cause an engine stall, increasing the risk of a crash.
NHTSAForest River, Inc. - Incorrect Weight Listed on Label/FMVSS 110
Forest River, Inc. - Incorrect Weight Listed on Label/FMVSS 110
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
FDA DeviceseTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesAllura Xper FD20/10; System Code: 722029;
Allura Xper FD20/10; System Code: 722029;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesBurlington Medical, Frontal Aprons
Burlington Medical, Frontal Aprons
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesMiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA DevicesJiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
FDA DevicesBurlington Medical, Demi Half Aprons.
Burlington Medical, Demi Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DrugsMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.