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

2,324 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

Prima Vera Nueva Recalls Tamales Due to Listeria Risk

Prima Vera Nueva recalled 30,327 packages of Butternut Squash Tamales on December 12, 2025. The product poses a high risk of contamination with Listeria monocytogenes. Consumers should not consume these tamales and should seek a refund or replacement.

Prima Vera Nueva
Potential contamination
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Liquid Adhesive Hazard

Medline Industries, LP recalled 1,928 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive linked to cracking tubing during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Over Hazardous Adhesive

Medline Industries recalled 236 medical procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive that may cause butyrate tubing to crack. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Adhesive Hazard

Medline Industries recalled 1,928 medical procedure convenience kits on December 12, 2025, due to a risk of crack in the adhesive tubing. The kits contain MASTISOL liquid adhesive, leading to safety concerns. Healthcare providers and patients should stop using the kits immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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