Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
CPSCSAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Amazon by SAMIT Outdoor
SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Amazon by SAMIT Outdoor
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
CPSCJoly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labeling Requirements
Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labeling Requirements
The recalled vinegar product violates the precautionary labeling requirements under the Federal Hazardous Substances Act (FHSA) because the hazardous substance lacks required warning labels and first-aid treatment instructions. This poses a deadly risk of poisoning if the contents are swallowed and a serious injury from chemical burns to the skin and eyes if improperly handled.
FDA DrugsOxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
FDA DevicesHalyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
FDA FoodAonic Complete Hers. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be taken orally as a dietary supplement. Shipping unit: two 15 count decorated boxes in a corrugated Aonic Master Shipper. Firm Name and Address on Label: Aonic Inc. 2261 MarketStreet #5416 San Francisco, CA 94114 USA.
Aonic Complete Hers. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be taken orally as a dietary supplement. Shipping unit: two 15 count decorated boxes in a corrugated Aonic Master Shipper. Firm Name and Address on Label: Aonic Inc. 2261 MarketStreet #5416 San Francisco, CA 94114 USA.
Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination.
FDA DrugsTestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
FDA FoodCarrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
Carrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
Contains undeclared sesame
FDA FoodSpicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.
Spicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.
foreign material (small hard plastic fragments)
FDA DrugsTestosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodBrand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores
Brand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores
Product may contain foreign material.
FDA DrugsUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
FDA DrugsTestosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodCarrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
Contains undeclared sesame
FDA DevicesMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA DrugsTestosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesMedline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DevicesIQon Spectral CT; Product Code (REF): 728332;
IQon Spectral CT; Product Code (REF): 728332;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
FDA Drugsthiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Lack of Assurance of Sterility
FDA DevicesSpectral CT; Product Code (REF): 728333;
Spectral CT; Product Code (REF): 728333;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
FDA DevicesIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA DevicesAzurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA DevicesBrilliance iCT; Product Code (REF): 728306;
Brilliance iCT; Product Code (REF): 728306;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.