Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesBurlington Medical, Blockers.
Burlington Medical, Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
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 DevicesBurlington Medical, Protective Sleeves.
Burlington Medical, Protective Sleeves.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesAllura Xper FD20/15; System Code: 722058;
Allura Xper FD20/15; System Code: 722058;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA FoodPrickly Pear Jelly. 9 oz (268 g) glass bottle with gold cap.
Prickly Pear Jelly. 9 oz (268 g) glass bottle with gold cap.
Undeclared milk.
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.
FDA DevicesBurlington Medical, Frontal Aprons
Burlington Medical, Frontal Aprons
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesBurlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
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 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 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 FoodCoconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatty acid esters, sucrose fatty acid esters]; Storage Condition: Room temperature; Manufactured in: Hainan, China; imported By: HK HEYTEA FOOD AND BEVERAGE MANAGEMENT LIMITED; For catering establishment; UPC: 673367992785
Coconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatty acid esters, sucrose fatty acid esters]; Storage Condition: Room temperature; Manufactured in: Hainan, China; imported By: HK HEYTEA FOOD AND BEVERAGE MANAGEMENT LIMITED; For catering establishment; UPC: 673367992785
Product contains undeclared milk.
FDA DrugsPrazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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 DrugsSTERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3
Lack of Assurance of Sterility
FDA DevicesAirway Exam Kit, DYKE1796
Airway Exam Kit, DYKE1796
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
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.
FDA FoodDivided Sunset Multi Collagen Peptides, 8 Ounce, Stand-up Pouch, UPC Code: 8 50005 60689 5
Divided Sunset Multi Collagen Peptides, 8 Ounce, Stand-up Pouch, UPC Code: 8 50005 60689 5
The product states wild caught marine collagen and eggshell membrane collagen in ingredient statement but does not state EGG and the specific species of FISH parenthetically or via a Contains statement.
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 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 DevicesMiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
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 FoodMEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, 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: 6912449124312
MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, 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: 6912449124312
Products contain cyclamates (banned sweetener)
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.