cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

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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Recalled Uuoeebb Infant Walker in gray
HIGH
CPSC

BaoD Recalls Uuoeebb Infant Walkers Sold on Amazon for Fall and Entrapment Hazards (2025)

BaoD recalled Uuoeebb Infant Walkers sold on Amazon after safety hazards were identified. The walker can fit through a standard doorway and does not stop at a step edge, creating a fall hazard. The leg openings can allow a child to slip down until the head becomes entrapped. Consumers should stop using the recalled walker immediately and contact BaoD for a full refund.

Uuoeebb
The recalled
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Recalled MY26 Domane+ ALR 5 Electric Bicycle
MEDIUM
CPSC

TREK Recalls 4 Electric Bicycles Over Chainring Bolt Hazard (2026 Domane+ ALR 5, ALR 6 AXS, Checkpoi

TREK recalled four electric bicycles sold through Trek authorized retailers and independent bike shops nationwide and online. The chainring bolts can loosen, causing the chainring to detach and create a fall hazard. Owners should stop riding immediately and contact an authorized Trek dealer for a free repair; Trek provides a $20 in-store credit toward Trek, Electra, or Bontrager merchandise, valid

TREK
The bolts
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Health & Personal Care
HIGH
FDA DEVICE

Fujirebio Diagnostics Recalled pTau 217 Plasma Cartridges

Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.

Fujirebio Diagnostics
Customers may
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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Calibrators

Fujirebio Diagnostics has recalled 117 units of Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results. The recall was announced on December 11, 2025, after customers reported false classifications of Alzheimer’s disease. Affected products were distributed nationwide, including in states like California and Florida.

Fujirebio Diagnostics
Customers may
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Recalled Vevor Ice Crusher, model number BY-300 in yellow (SBY-300FD110V3ZIQV1)
HIGH
CPSC

Sanven Technology Recalls Vevor Ice Crushers for Fire Hazard (2025)

Sanven Technology recalled Vevor ice crushers after a fire hazard was identified in BY-300 and BY-300 FS models. The units, sold as Ice Shavers, Ice Crushers and Snow Cone Makers, can experience a thermal event that could ignite. Stop using the recalled devices immediately and contact Sanven Technology for a full refund.

Sanven Technology
The ice
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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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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled 38 Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The affected systems may have been relocated without adequate support, risking serious injury. No incidents have been reported, but the recall is classified as a Class II hazard.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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Food & Beverages
HIGH
FDA FOOD

Publix Coffee Cake Recalled Due to Undeclared Walnuts

Publix recalled 811 cases of Raspberry Coffee Cake on December 10, 2025. The product contains undeclared walnuts, posing a serious allergen risk. Consumers should not consume the product and seek a refund.

The James Skinner
Undeclared allergen
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Health & Personal Care
HIGH
FDA DEVICE

GE Healthcare Recalls Nuclear Medicine Systems Due to Fall Hazard

GE Healthcare recalled seven Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The recall affects systems that have exceeded their End of Guaranteed Service. No injuries or falls have been reported.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Due to Fall Risk

GE HealthCare recalled 12 Nuclear Medicine systems on December 10, 2025, due to a potential fall hazard. The affected systems may have inadequate support during transport, risking detector integrity. No injuries have been reported, but the risk of life-threatening incidents exists.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled three Nuclear Medicine systems on December 10, 2025. The recall follows concerns over inadequate detector support, which could lead to a fall and serious injury. No incidents have been reported to date.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

Mazor Robotics Recalls Robotic Guidance System Over Software Errors

Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.

Mazor Robotics
Software errors
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Health & Personal Care
HIGH
FDA DEVICE

REPLIGEN Spectrometer Recalled Due to Laser Hazard

REPLIGEN Corporation recalled 33 Maverick Measurement Module Spectrometers on December 10, 2025. Disconnected or poorly crimped cables may cause elevated laser output or unintended firing. The recall affects devices distributed in the U.S.

REPLIGEN
Potential Elevated
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