cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Aju Pharm Recalls Dual Thread Screw-In Anchors Over Device Failures

Aju Pharm Co. recalled 400 Dual Thread Screw-In Anchors on December 17, 2025. The recall follows reports of device failures including breakage and pull-out incidents. Healthcare providers and patients should stop using these devices immediately.

Aju Pharm Co.
Reports of
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Food & Beverages
HIGH
FDA FOOD

H-E-B Coconut Yogurt Recalled for Undeclared Almonds

H-E-B recalled 175 cases of Higher Harvest Dairy Free Coconut Based Yogurt on December 17, 2025. The product contains undeclared almonds, posing a serious allergy risk. Consumers should stop using the yogurt immediately and contact the company for refunds.

Plant Based Innovations
Contains undeclared
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Food & Beverages
HIGH
FDA FOOD

BarbaCuban White Truffle Sauce Recalled for Undeclared Quinine

BarbaCuban recalled 12,214 bottles of White Truffle Sauce on December 17, 2025, due to undeclared quinine. The affected product poses a high risk to consumers. Customers should not consume the sauce and seek refunds immediately.

Prima Foods International
Undeclared Quinine
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Food & Beverages
HIGH
FDA 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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Food & Beverages
HIGH
FDA 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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Food & Beverages
HIGH
FDA FOOD

Prima Foods Recalls BarbaCuban 455 Sauce Over Undeclared Quinine

Prima Foods International recalled 12,214 bottles of BarbaCuban 455 Everything Sauce on December 17, 2025. The sauce contains undeclared quinine, posing a health risk to consumers. Affected products were distributed in Florida with best by dates from January to June 2026.

Prima Foods International
Undeclared Quinine
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Food & Beverages
HIGH
FDA 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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Food & Beverages
HIGH
FDA FOOD

Prima Foods Recalls BarbaCuban Havana Gold Over Quinine Hazard

Prima Foods International recalled 12,214 bottles of BarbaCuban Havana Gold due to undeclared quinine. The recall affects products distributed in Florida. Consumers should not consume the product and seek refunds immediately.

Prima Foods International
Undeclared Quinine
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Food & Beverages
HIGH
FDA FOOD

Prima Foods Recalls Ketchup Over Undeclared Quinine Hazard

Prima Foods International recalled 12,214 bottles of BarbaCuban Ram Air Red Zesty Ketchup on December 17, 2025. The product contains undeclared quinine, a chemical that can pose health risks. Consumers should not consume this product and should seek refunds or replacements.

Prima Foods International
Undeclared Quinine
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Food & Beverages
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Forceps and Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 disposable forceps and cannula on December 16, 2025, due to potential bioburden contamination. The recall affects various models distributed worldwide, including 8,651 in the U.S. and 6,138 internationally. Users should stop using these devices immediately to prevent infection risk.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Illuminated Depressor Due to High Hazard

Vortex Surgical recalled 14,789 units of the TID Pharos Illuminated Depressor on December 16, 2025. The recall affects 8,651 units in the U.S. and 6,138 units internationally. Patients and healthcare providers should cease use immediately due to a high hazard level.

Vortex Surgical
XXX
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Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Due to Missing Imprint

SpecGx LLC recalled 287,988 bottles of Oxycodone and Acetaminophen tablets on December 16, 2025. The tablets may lack proper imprinting, posing risks for misuse and confusion. Healthcare providers and consumers must stop using the product immediately and seek guidance.

SpecGx LLC
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medical Kits Recalled Due to Suction Irrigator Hazards

Medline recalled 41,432 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak or emit vaporized saline. This defect poses a high risk of injury during medical procedures.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medical Kits Recalled Over Strykeflow 2 Suction Hazard

Medline recalled 4,536 medical procedure kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. The recall affects various models used in surgeries nationwide.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Kits Due to Suction Irrigator Leak Hazard

Medline Industries recalled 96 medical procedure convenience kits on December 16, 2025. The recall affects kits containing Stryker's Strykeflow 2 Suction Irrigators due to a design flaw causing leaks. Patients and healthcare providers must stop using these kits immediately.

Medline Industries, LP
Medline kits
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