cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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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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 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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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

Elekta Recalls MOSAIQ Oncology System Over Overtreatment Risk

Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.

Elekta
Using oncology
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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 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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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

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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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

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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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls 2,095 da Vinci S, Si EndoWrist Tenaculum Forceps Instrument (2025)

Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S, Si Grasping Retractor Instrument Recalled for 2,660 Units (2026)

Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Heraeus Medical Recalls PALACOS Bone Cement Due to Ampoule Breakage

Heraeus Medical GmbH recalled PALACOS R pro 40 and R pro 80 bone cement on December 9, 2025. The recall follows multiple complaints of ampoule breakage affecting product usability. Healthcare providers must stop using the product immediately.

Heraeus Medical GmbH
increase of
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Vehicles & Parts
HIGH
NHTSA

Hyundai IONIQ 6 Recall Expands for Charging Port Door Detachment

Hyundai Motor America recalls 2023-2025 IONIQ 6 electric vehicles due to a charging port door panel that may detach. Dealers will apply adhesive as the remedy. Owner letters begin November 10, 2025. VINs searchable on NHTSA as of September 13, 2025.

Hyundai
A detached
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Health & Personal Care
HIGH
FDA DEVICE

Heraeus Medical Recalls PALACOS Bone Cement Due to Ampoule Breakage Hazard

Heraeus Medical GmbH recalled PALACOS MV pro 40 and MV pro 80 bone cement on December 9, 2025. The recall follows numerous complaints about ampoule breakage. This defect can prevent proper cement dough formation, rendering the product unusable for patients.

Heraeus Medical GmbH
increase of
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