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 DEVICE

Medline Medical Kits Recalled Due to Cracked Tubing Hazard

Medline Industries, LP recalled 857 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive which can cause butyrate tubing to crack during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
Read more
HIGHFDA DEVICE

Medline Medical Procedure Kits Recalled Over Adhesive Hazard

Medline Industries recalled 456 medical procedure kits on December 12, 2025, due to a potential hazard involving MASTISOL liquid adhesive. The defective butyrate tubing may crack during use, posing a risk to patients and healthcare providers. Consumers must stop using these kits immediately and seek further instructions.

Medline Industries, LP
Medline kits
Read more
HIGHFDA FOOD

Prima Vera Nueva Recalls Tamales Due to Listeria Risk

Prima Vera Nueva recalled 16,790 packages of Black Bean Bonanza Tamales on December 12, 2025. The company cited potential contamination with Listeria monocytogenes, a serious foodborne pathogen. Consumers should not eat these tamales and should seek a refund or replacement.

Prima Vera Nueva
Potential contamination
Read more
HIGHFDA DEVICE

Elekta Recalls Leksell GammaPlan Software Due to High Radiation Risks

Elekta recalled the Leksell GammaPlan Radionuclide RT Treatment Planning System on December 12, 2025. The software, used for treatment planning, may incorrectly irradiate patient locations due to a stereotactic reference error. This recall affects users worldwide, including in the U.S. and various international locations.

Elekta
Due to
Read more
HIGHFDA DEVICE

Bard Peripheral Vascular Recalls CV Catheter Due to Sterility Risk

Bard Peripheral Vascular Inc. recalled 14,935 units of the Broviac 4.2 Fr Single-Lumen CV Catheter Tray on December 12, 2025. Damage to the outer tray may compromise the sterile barrier, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Bard Peripheral Vascular
Due to
Read more
HIGHFDA DEVICE

Applied Medical Resources Recalls Cannula Due to Blade Hazard

Applied Medical Resources recalled 450 units of the Kii Low Profile, Bladed Dual Pack on December 11, 2025, due to a potential safety issue. The blade obturator may extend beyond safe limits after assembly, posing a risk to patients. Healthcare providers and patients should stop using the device immediately.

Applied Medical Resources
There is
Read more
Recalled Vevor Ice Crusher, model number BY-300 in yellow (SBY-300FD110V3ZIQV1)
HIGH
CPSC

Sanven Technology Recalls Vevor Ice Crushers Over Fire Hazard

Sanven Technology recalled Vevor ice crushers on December 11, 2025, due to a fire hazard. The recall affects models BY-300 and BY-300 FS, which can ignite during use. Consumers must stop using these products and seek a refund immediately.

Sanven Technology
The ice
Read more
Recalled YCXXKJ Baby Bath Seat and Toys – blue
HIGH
CPSC

YCXXKJ Baby Bath Seats Recalled Over Drowning Risk

BenTalk recalled YCXXKJ-branded baby bath seats on December 11, 2025. The recall affects models that violate safety standards and pose a drowning risk. Consumers should stop using the product immediately and seek a refund.

YCXXKJ Baby Bath Seats
The recalled
Read more
Recalled X-PRO ATV Eagle 40cc (front view)
HIGH
CPSC

Luyuan Recalls Youth ATVs Over Crash Hazard Risk

Luyuan recalled X-Pro Eagle 40cc and FRP Sahara 40cc Youth ATVs on December 11, 2025. The ATVs violate mandatory safety standards and pose serious injury risks. Consumers must stop using the ATVs and contact Luyuan for a free repair.

Yongkang Luyuan Industrial & Trading Co., Ltd., of China
The recalled
Read more
Recalled VEVOR Garment Steamer – side view
HIGH
CPSC

Sanven Technology Recalls VEVOR Steamers Over Burn Hazard

Sanven Technology recalled VEVOR Garment Steamers on December 11, 2025, due to burn hazards. Users reported risks of leaking hot water and steam. Consumers should stop using the product and seek refunds immediately.

Sanven Technology
The steamers
Read more
Recalled SKCAIHT Children's Mermaid Costume
HIGH
CPSC

SKCAIHT Recalls Children's Costumes Over Phthalate Exposure Risk

SKCAIHT recalled children's mermaid costumes on December 11 due to a risk of injury from phthalate exposure. The costumes, sold on Amazon, violate federal regulations concerning toxic substances. Consumers should stop using the costumes immediately and seek a refund.

SKCAIHT Children's Costumes
The children's
Read more
Recalled Uuoeebb Infant Walker in gray
HIGH
CPSC

Uuoeebb Infant Walkers Recalled Over Fall and Entrapment Hazards

Uuoeebb recalled infant walkers on December 11, 2025 due to fall and entrapment hazards. The recall affects collapsible walkers with eight wheels and adjustable heights. Consumers should stop using the product immediately and seek a refund.

Uuoeebb Infant Walkers
The recalled
Read more
HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse ¿-Amyloid Controls Over Test Inaccuracy

Fujirebio Diagnostics recalled 179 units of Lumipulse ¿-Amyloid Plasma Controls on December 11, 2025. The recall stems from inaccurate test results leading to potential misclassification of Alzheimer's disease. Customers should stop using the device immediately and follow the manufacturer's instructions.

Fujirebio Diagnostics
Customers may
Read more
HIGHFDA FOOD

Ukrop's Pound Cake Recalled Due to Undeclared Soy Allergen

Ukrop's Homestyle Foods recalled 61 units of its 6" Pound Cake on December 11, 2025. The product contains undeclared soy, posing a risk to those with soy allergies. The cakes were distributed to Virginia and West Virginia.

Ukrop's Homestyle Foods
Undeclared Soy.
Read more
HIGHFDA DEVICE

Fujirebio Diagnostics Issues Recall for Inaccurate Test Results

Fujirebio Diagnostics recalled 1,423 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects models found to provide inaccurate test results, potentially misclassifying Alzheimer's disease. Healthcare providers and patients should stop using these cartridges immediately.

Fujirebio Diagnostics
Customers may
Read more
HIGHFDA FOOD

Ukrop's Pound Cake Recalled for Undeclared Soy Allergen

Ukrop's Homestyle Foods recalled 61 units of 6" Pound Cake on December 11, 2025. The product contains undeclared soy, posing a high risk to those with soy allergies. Affected cakes were shipped to Virginia and West Virginia.

Ukrop's Homestyle Foods
Undeclared Soy.
Read more
HIGHFDA FOOD

Ukrop's Pound Cakes Recalled Due to Undeclared Soy Risk

Ukrop's Homestyle Foods recalled two pound cake products on December 11, 2025, due to undeclared soy. Consumers with allergies to soy are at risk of serious allergic reactions. A total of 61 cakes were shipped to Virginia and West Virginia.

Ukrop's Homestyle Foods
Undeclared Soy.
Read more
Advertisement