cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

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
Read more
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
Read more
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
Read more
Food & Beverages
HIGH
FDA 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
Read more
Health & Personal Care
HIGH
FDA 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
Read more
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
Read more
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
Read more
Health & Personal Care
HIGH
FDA DRUG

CareFusion Recalls ChloraPrep Swabsticks Due to Sterility Concerns

CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.

ChloraPrep
Lack of
Read more
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
Read more
Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical IOL Marker Recalled Over Infection Risk

Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.

Vortex Surgical
There may
Read more
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
Read more
Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Over Missing Imprint

SpecGx LLC recalled 74,544 bottles of Oxycodone and Acetaminophen Tablets on December 16, 2025. The tablets may lack an imprint, raising serious identification issues. Consumers should stop using these medications immediately and contact their healthcare providers for guidance.

OXYCODONE AND ACETAMINOPHEN
Failed Tablet/Capsule
Read more
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
Read more
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
Read more
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
Read more
Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Kits Over High Burn Risk

Medline Industries recalled 1,457 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. Healthcare providers and patients must stop using the devices immediately.

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

Vortex Surgical Recalls Vitrectomy Lenses Due to Infection Risk

Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices immediately.

Vortex Surgical
There may
Read more
Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Urology Kits Over Leak and Vapor Risks

Medline recalled 12 medical procedure kits on December 16, 2025, due to leaking issues. The kits contain Stryker's Strykeflow 2 Suction Irrigators, which can emit vaporized saline resembling smoke. Patients and healthcare providers must stop using these devices immediately.

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

Vortex Surgical Recalls Internal Delivery Device Over Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA I.D.D. Internal Delivery Device on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches that may compromise sterility, leading to infection risks. Healthcare providers and patients are urged to stop using the device immediately and follow recall instructions.

Vortex Surgical
There may
Read more