All Product Recalls

Browse through 1,540 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

CareFusion 303 Recalls Automated Dispensing Cabinets Due to Error Risk

CareFusion 303 recalled 53,669 units of Automated Dispensing Cabinets on November 20, 2025. A firmware update caused drawer failures, leading to potential delays in accessing medications. This recall affects devices distributed worldwide, including all U.S. states and several countries.

CareFusion 303
Automated Dispensing
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HIGHFDA FOOD

A New Life Herbs Recalls Baby Allergy Herbal Supplement Over Label Issues

A New Life Herbs, LLC recalled 23 bottles of its Baby Allergy Herbal Supplement on November 20, 2025. The recall follows unapproved drug claims and absence of a Supplement Facts label on the product. Consumers should not consume the supplement and should seek refunds immediately.

A New Life Herbs
Unapproved drug
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HIGHFDA FOOD

Sonex Aluminum Pot Recalled Over Lead Contamination Risk

Sonex recalled two aluminum pots on November 19, 2025, due to leachable lead levels of 0.323mg/L. The recall affects products distributed in New York. Consumers must stop using the product and seek refunds or replacements.

Alanwar Food
Products found
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HIGHFDA DEVICE

Vortex Surgical Recalls Laser Probe Due to Smooth Passage Issues

Vortex Surgical recalled 221 units of the 25ga Illuminated Flex-Tip Laser Probe on November 19, 2025. The product does not pass through a 25ga cannula smoothly, which poses a high hazard risk. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

Vortex Surgical
Reason for
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HIGHFDA DEVICE

Steris Washers Recalled Due to Electrical Arcing Hazard

Steris recalled 22 AMSCO 7053HP Washer/Disinfectors on November 19, 2025, due to a risk of electrical arcing. The issue arises from a wire connected to the electrical box that may shift from its intended position. Users must stop using the device immediately and follow recall instructions.

Steris
Wire connected
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HIGHFDA FOOD

JR Simplot Recalls Tater Gems Due to Plastic Fragments

JR Simplot Company recalled 7,053 cases of Traditional Reduced Sodium Tater Gems on November 18, 2025. The recall is due to plastic fragments embedded in the product, posing a choking hazard. Consumers in 15 states are advised not to consume the affected items.

JR Simplot
Plastic fragments.
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Nebivolol Tablets Over Contamination

Glenmark Pharmaceuticals recalled 672 bottles of Nebivolol Tablets on November 18, 2025, due to cross-contamination. The 20 mg tablets, prescribed for hypertension, may pose health risks. Consumers should stop using the product and seek guidance from healthcare providers.

NEBIVOLOL
Cross Contamination
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HIGHFDA FOOD

Zimi Puff Pastry Recalled Due to Partially Hydrogenated Oils

Karabetian Import and Distribution recalled 338 boxes of Zimi Puff Pastry on November 18, 2025. The recall was initiated due to the presence of partially hydrogenated oils, which are not permitted in foods exported to the U.S. Consumers should not consume the product and seek a refund or replacement.

Karabetian Import and Distribution
partially hydrogenated
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HIGHFDA FOOD

Karabetian Import and Distribution Recalls Frozen Kunefe for PHOs

Karabetian Import and Distribution recalled 338 boxes of Zimi Kunefe on November 18, 2025, due to partially hydrogenated oils. The recall affects frozen dessert products distributed in nine states including California and Texas.

Karabetian Import and Distribution
partially hydrogenated
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HIGHFDA DEVICE

AGFA Recalls Digital Radiography X-Ray System Over Radiation Risk

AGFA Healthcare recalled 35 Digital Radiography X-Ray systems on November 18, 2025, due to a risk of exceeding safe radiation levels. The recall affects systems distributed nationwide in the U.S. Users must stop using the device immediately and follow manufacturer instructions.

AGFA Healthcare
It is
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HIGHFDA DEVICE

Sheathing Technologies Recalls Ultrasound Probe Covers Over Infection Risk

Sheathing Technologies recalled 12 units of its ultrasound probe covers on November 17, 2025, due to potential contamination risks. The non-sterile vaginal and rectal covers may have defects that pose an infection risk during use. Consumers should stop using the product immediately and follow the manufacturer's instructions.

Sheathing Technologies
Vaginal/rectal ultrasound
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HIGHFDA FOOD

Prime Food Processing Recalls Lava Bun Over Undeclared Milk Hazard

Prime Food Processing recalled 2,243 cases of Lava Bun with Green Tea Flavor on November 16, 2025. The product does not declare milk in its ingredient statement, posing a risk to consumers with milk allergies. The recall affects 16 states including California, Texas, and Florida.

Prime Food Processing
Products do
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HIGHFDA FOOD

Prime Food Processing Recalls Lava Buns Over Undeclared Milk

Prime Food Processing LLC recalled 2,243 cases of Lava Buns with Salted Egg Yolk on November 16, 2025. The recall occurred due to undeclared milk in the product's ingredient statement. This poses a high risk to individuals with milk allergies.

Prime Food Processing
Products do
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HIGHFDA DRUG

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk

Cipla USA recalled 12,576 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025, due to a nitrosamine impurity. The impurity, N-nitroso-cinacalcet, exceeds acceptable daily intake limits. Consumers must stop using this product immediately and contact healthcare providers for guidance.

CINACALCET
CGMP Deviations:
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HIGHFDA DRUG

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Nitrosamine Hazard

Cipla USA, Inc. recalled 15,744 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall follows the discovery of a nitrosamine impurity exceeding acceptable daily intake limits. Consumers should stop using the product immediately and consult healthcare providers.

CINACALCET
CGMP Deviations:
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