États-Unis Recalls

Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.

Showing 24 of 17,563 results
PharmaceuticalUSFDA Drugs

ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

Presence of Foreign substance - potential presence of metal particulate matter

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

Testosterone, 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)
Food & BeverageUSFDA Food

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.

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
PharmaceuticalUSFDA Drugs

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Meitheal Pharmaceuticals, Inc
FDA DrugsClass II

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Defective Delivery System: Missing or duplicated needles within the injection kit

Feb 18, 2026Meitheal Pharmaceuticals, Inc
Food & BeverageUSFDA Food

Carrot 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
PharmaceuticalUSFDA Drugs

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Lack of Assurance of Sterility

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

Presence of Foreign substance - potential presence of metal particulate matter

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Lack of Assurance of Sterility

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

Testosterone 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)
Medical DeviceUSFDA Devices

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

Medline Industries, LP
FDA DevicesClass I

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

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
PharmaceuticalUSFDA Drugs

ESTRADIOL, 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)
Medical DeviceUSFDA Devices

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

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.
Medical DeviceUSFDA Devices

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

Laerdal Medical Corporation
FDA DevicesClass II

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.

Feb 18, 2026Laerdal Medical Corporation
Medical DeviceUSFDA Devices

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

Medline Industries, LP
FDA DevicesClass II

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

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
PharmaceuticalUSFDA Drugs

ESTRADIOL, 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)
PharmaceuticalUSFDA Drugs

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

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
PharmaceuticalUSFDA Drugs

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Lack of Assurance of Sterility

Feb 18, 2026Fresenius Kabi Compounding, LLC
Medical DeviceUSFDA Devices

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD
FDA DevicesClass III

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Feb 18, 2026SUREPULSE MEDICAL LTD
PharmaceuticalUSFDA Drugs

ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

Presence of Foreign substance - potential presence of metal particulate matter

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
Food & BeverageUSFDA Food

Aonic Complete His. 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. Sipping 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 His. 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. Sipping 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
Medical DeviceUSFDA Devices

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD
FDA DevicesClass III

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Feb 18, 2026SUREPULSE MEDICAL LTD
Medical DeviceUSFDA Devices

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

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
PharmaceuticalUSFDA Drugs

Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

Presence of Foreign substance - potential presence of metal particulate matter

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

Testosterone 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)

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