cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Azurion Systems Over Software Issues

Philips recalled 10,466 Azurion Systems on December 12, 2025, due to six software issues that can cause system failures. Users must stop using the devices immediately. The recall affects models sold worldwide, including in the U.S.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Six (6)
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Health & Personal Care
HIGH
FDA DEVICE

Integra LifeSciences Recalls ICP Sensor Kit Over Corrosion Risk

Integra LifeSciences Corp. recalled 5,116 units of the Codman CereLink ICP Sensor Basic Kit on December 12, 2025. The recall stems from potential corrosion stains on the included 14-gauge Tuohy needle. Healthcare providers and patients must stop using the device immediately and follow the recall instructions.

Integra LifeSciences Corp.
Potential corrosion
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Patient Monitors Over Connectivity Issue

Philips recalled 13,470 Smart-hopping 2.0 AP Patient Monitors on December 12, 2025. The MX40 device failed to reconnect to the PIC iX under certain conditions, posing a high risk to patient monitoring. Healthcare providers should stop using the device immediately and follow recall instructions.

Philips North America
It was
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Food & Beverages
HIGH
FDA FOOD

House Of Flavors Recalls Banana Pudding Ice Cream Over Allergen Risk

House Of Flavors, Inc. recalled 2,388 units of 1972 Banana Pudding Ice Cream on December 12, 2025. The recall occurred due to undeclared soy lecithin, posing a risk to consumers with soy allergies. Products were distributed across 12 states including Alabama, Arizona, and New York.

House Of Flavors
Undeclared soy
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Nerve Block Tray Kits Over Cracked Tubing Risk

Medline Industries recalled medical procedure convenience kits labeled as Nerve Block Tray 2 on December 12, 2025. The recall affects kits containing MASTISOL liquid adhesive due to complaints of cracked butyrate tubing during vial actuation. Healthcare providers and patients should stop using these kits immediately.

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

Medline Medical Kits Recalled Over Tubing Cracking Hazard

Medline Industries recalled 60 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive which has a defect causing butyrate tubing to crack. Users must stop using the kits immediately and follow recall instructions.

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

Philips Azurion System Recalled Due to Software Malfunction

Philips recalled 228 Azurion systems on December 12, 2025, due to software issues that may cause loss of X-ray functionality. The problems can result in incorrect image content and motorized movement failure. Affected devices were distributed internationally across multiple countries.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medical Kits Recalled Due to Hazardous Adhesive

Medline recalled multiple medical procedure convenience kits on December 12, 2025. The recall affects 66 units containing MASTISOL liquid adhesive. The adhesive's tubing may crack, posing a serious risk during use.

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

Medline Circumcision Kits Recalled Over Adhesive Hazard

Medline Industries, LP recalled 1,928 circumcision procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive, which may crack during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Tamales Recalled Over Listeria Contamination

Prima Vera Nueva recalled 31,672 packages of Roasted Green Chile & Jack Cheese Tamales on December 12, 2025. The recall is due to potential contamination with Listeria monocytogenes, a harmful bacteria. Consumers should not consume the product and seek refunds or replacements.

Prima Vera Nueva
Potential contamination
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Recalls Butternut Squash Tamales for Listeria Risk

Prima Vera Nueva recalled 18,876 packages of Butternut Squash Tamales on December 12, 2025, due to potential contamination with Listeria monocytogenes. The recall affects products distributed in California and Nevada. Consumers should not consume the tamales and seek refunds or replacements.

Prima Vera Nueva
Potential contamination
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Tamales Recalled for Listeria Risk

Prima Vera Nueva recalled 9,656 packages of Roasted Pumpkin & White Cheddar Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes. Consumers should not eat these tamales and seek refunds immediately.

Prima Vera Nueva
Potential contamination
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Tamales Recalled Due to Listeria Risk

Prima Vera Nueva recalled 16,264 packages of Mushroom, Spinach & Salsa Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes, a serious foodborne illness. Consumers should not eat the product and seek a refund.

Prima Vera Nueva
Potential contamination
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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 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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