These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA FOOD

CATAO MARKET Recalls Cuban Loaf Cake Over Undeclared Color Additive

CATAO MARKET recalled 520 master cases of its Authentic Cuban Loaf Cake Raisins on December 18, 2025. The recall occurred due to undeclared FD&C Yellow #5, which poses a high allergy risk. The affected products were distributed only in Florida and have best by dates from December 18, 2025, to March 18, 2026.

CATAO MARKET
Undeclared colors
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HIGHFDA DEVICE

Wilson-Cook Medical Recalls Bipolar Sphincterotomes Due to Hazard

Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.

Wilson-Cook Medical
Due to
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HIGHFDA FOOD

Rovira Biscuit Recalls Tita Crackers Due to Undeclared Colors

Rovira Biscuit Corporation recalled 29,246 units of Tita Crackers on December 17, 2025. The recall stems from undeclared colors FD&C Yellow #6 and FD&C Red 40. Consumers in GA, TX, MA, IL, MD, USVI, and Puerto Rico should not consume these products.

Rovira Biscuit
Undeclared colors
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HIGHFDA FOOD

Rovira Biscuit Recalls Snack Crackers Over Undeclared Colors

Rovira Biscuit Corporation recalled 6,671 units of Snack Crackers on December 17, 2025. The recall follows the discovery of undeclared FD&C Yellow #6 and FD&C Red 40 in the products. The affected crackers were distributed across several states, including Georgia and Texas.

Rovira Biscuit
Undeclared colors
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HIGHFDA FOOD

Rovira Crackers Recalled for Undeclared Artificial Colors

Rovira Biscuit Corporation recalled 71,492 units of Vanilla Treats Crackers on December 17, 2025. The product contains undeclared FD&C Yellow #6 and FD&C Red 40. Consumers should not consume the crackers and should seek refunds.

Rovira Biscuit
Undeclared colors
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HIGHFDA FOOD

Rovira Biscuit Recalls Crackers Over Undeclared Color Additives

Rovira Biscuit Corporation recalled 9,838 units of Tempting Crackers Tray on December 17, 2025. The recall stems from undeclared colors FD&C Yellow #6 and FD&C Red 40. The affected products were distributed in several states, including Georgia and Texas, as well as Puerto Rico.

Rovira Biscuit
Undeclared colors
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HIGHFDA FOOD

Baraka Gourmet Kunafe Recalled Due to Harmful Oils

Baraka Gourmet Pastry Kunafe, 6.7oz, has been recalled due to potential contamination with partially hydrogenated oils. The recall affects 575 cases distributed nationwide. Consumers should stop using the product and seek a refund or replacement.

ZIYAD BROTHERS IMPORTING
May contain
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HIGHFDA FOOD

ZIYAD Brothers Recalls Puff Pastry Over Hydrogenated Oils Hazard

ZIYAD Brothers Importing recalled 2,865 cases of French Style Puff Pastry on December 17, 2025. The product may contain partially hydrogenated oils, posing a health risk. Consumers should not consume the product and seek refunds immediately.

ZIYAD BROTHERS IMPORTING
May contain
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HIGHFDA FOOD

Rovira Biscuit Recalls Vanilla Econo Cookies Over Undeclared Colors

Rovira Biscuit Corporation recalled over 22,000 boxes of Vanilla Econo cookies on December 17, 2025. The recall affects cookies containing undeclared colors FD&C Yellow #6 and FD&C Red 40, which may pose health risks. The affected products were distributed in Georgia, Texas, Massachusetts, Illinois, Maryland, the U.S. Virgin Islands, and Puerto Rico.

Rovira Biscuit
Undeclared colors
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HIGHFDA FOOD

Prima Foods Recalls Marinade Due to Undeclared Quinine Hazard

Prima Foods International recalled 12,214 bottles of its 90 Miles to Mojo Marinade on December 17, 2025. The product contains undeclared quinine, posing a serious health risk. Consumers should not consume this product and should seek a refund immediately.

Prima Foods International
Undeclared Quinine
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HIGHFDA DEVICE

Aju Pharm Recalls Fixone Hybrid Anchor Due to Device Failures

Aju Pharm Co. recalled 233 Fixone Hybrid Anchors on December 17, 2025, due to multiple reports of device failures. The issues include anchor breakage, bending, and suture breakage. Patients and healthcare providers must stop using the device immediately.

Aju Pharm Co.
Reports of
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HIGHFDA DEVICE

Aju Pharm Recalls Screw-In Anchors Due to Device Failure

Aju Pharm Co. recalled 600 units of Genesis Screw-In Anchors on December 17, 2025. Reports indicate serious device failures, including anchor breakage and suture breakage. Healthcare providers and patients should stop using these anchors immediately.

Aju Pharm Co.
Reports of
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HIGHFDA DEVICE

Aju Pharm Recalls Genesis Knotless Anchor Due to Device Failure

Aju Pharm Co. recalled 1,163 units of Genesis Knotless Anchor on December 17, 2025, after reports of device failures. Issues include anchor breakage and suture breakage. Patients and healthcare providers must stop using the device immediately.

Aju Pharm Co.
Reports of
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HIGHFDA DEVICE

Aju Pharm Recalls Screw-In Anchor Due to Device Failure Risks

Aju Pharm Co. recalled 416 units of its AlternatiV+ Screw-In Anchor on December 17, 2025, after reports of significant device failures. The defects include anchor breakage, bending, and suture breakage. Patients and healthcare providers should stop using the device immediately.

Aju Pharm Co.
Reports of
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HIGHFDA DEVICE

Aju Pharm Recalls Biocomposite Anchor Due to Device Failures

Aju Pharm Co. recalled 1,088 units of its Fixone Biocomposite Anchor on December 17, 2025, due to serious device failures. Reports include anchor breakage, bending, and suture breakage. Healthcare providers and patients must stop using the device immediately.

Aju Pharm Co.
Reports of
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HIGHFDA DEVICE

Aju Pharm Recalls AlternatiV+ Max Knotless Anchor Due to Device Failures

Aju Pharm Co. recalled 2,569 units of the AlternatiV+ Max Knotless Anchor on December 17, 2025, following reports of device failures. Issues include anchor breakage and suture breakage, posing significant risks to patients. Consumers should stop using the device immediately and follow recall instructions.

Aju Pharm Co.
Reports of
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