Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,563 results
Medical Device
FDA Devices
FDA DevicesReprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
Medline Industries, LP
FDA DevicesClass I
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Feb 18, 2026Medline Industries, LP
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
Medical DeviceFDA Devices
FDA DevicesAzurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); 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.
Feb 18, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PharmaceuticalFDA Drugs
FDA DrugsTestosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
Food & BeverageFDA Food
FDA FoodCrunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.
Cacao Art
FDA FoodClass II
Crunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.
Undeclared allergen - milk. Product contains butter; cream is listed as a sub-ingredient of the butter, but milk is not declared in the ingredients or a contains statement.
Feb 18, 2026Cacao Art
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsTestosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsPro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11
Pro Numb Tattoo Numbing Spray LLC
FDA DrugsClass II
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11
cGMP deviations
Feb 18, 2026Pro Numb Tattoo Numbing Spray LLC
Food & BeverageFDA Food
FDA FoodCarrot Top Kitchens Lime Ginger Hummus; contains chickpeas, tahini, fresh ginger, lime juice & zest, salt; 8 oz.
Carrot Top Kitchens LLC
FDA FoodClass I
Carrot Top Kitchens Lime Ginger Hummus; contains chickpeas, tahini, fresh ginger, lime juice & zest, salt; 8 oz.
Contains undeclared sesame
Feb 18, 2026Carrot Top Kitchens LLC
Food & BeverageFDA Food
FDA FoodCarrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
Carrot Top Kitchens LLC
FDA FoodClass I
Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.
Contains undeclared sesame
Feb 18, 2026Carrot Top Kitchens LLC
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
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
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
Medical DeviceFDA Devices
FDA DevicesMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Medline Industries, LP
FDA DevicesClass II
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.
Feb 18, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Medline Industries, LP
FDA DevicesClass II
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
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.
Feb 18, 2026Medline Industries, LP
Food & BeverageFDA Food
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.
MG Foods-Compass Group
FDA FoodClass II
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)
Feb 18, 2026MG Foods-Compass Group
PharmaceuticalFDA Drugs
FDA DrugsTestosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
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
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
Food & BeverageFDA Food
FDA FoodOre-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag (6/5 lb bags), Net Wt. 30 lbs (13.6 kg)/ case. UPC on 30 lbs case label: 1 00 72714 00215 8. Manufactured by McCain Foods USA Inc. McCain distributed this product to foodservice accounts and product was not sold at retail stores.
McCain Foods USA Inc
FDA FoodClass II
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag (6/5 lb bags), Net Wt. 30 lbs (13.6 kg)/ case. UPC on 30 lbs case label: 1 00 72714 00215 8. Manufactured by McCain Foods USA Inc. McCain distributed this product to foodservice accounts and product was not sold at retail stores.
Foreign material (small hard plastic fragments).
Feb 18, 2026McCain Foods USA Inc
PharmaceuticalFDA Drugs
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
Amerisource Health Services LLC
FDA DrugsClass II
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.
Feb 18, 2026Amerisource Health Services LLC
PharmaceuticalFDA Drugs
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.
Fresenius Kabi Compounding, LLC
FDA DrugsClass II
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
Feb 18, 2026Fresenius Kabi Compounding, LLC
Food & BeverageFDA Food
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
Lee's Commissary
FDA FoodClass II
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.
Feb 18, 2026Lee's Commissary
Food & BeverageFDA Food
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.
TKS Co-pack Manufacturing, LLC
FDA FoodClass II
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.
Feb 18, 2026TKS Co-pack Manufacturing, LLC
Food & BeverageFDA Food
FDA FoodCarrot Top Kitchens Lemon & Garlic Hummus; contains chickpeas, tahini, lemon juice & zest, garlic, salt; 8 oz.
Carrot Top Kitchens LLC
FDA FoodClass I
Carrot Top Kitchens Lemon & Garlic Hummus; contains chickpeas, tahini, lemon juice & zest, garlic, salt; 8 oz.
Contains undeclared sesame
Feb 18, 2026Carrot Top Kitchens LLC
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)