cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si EndoWrist Recall 6,152 Instruments for Pitch Cable Frays (2026)

Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.

Intuitive Surgical
Due to
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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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Health & Personal Care
HIGH
FDA DEVICE

Heraeus Medical Recalls PALACOS Bone Cement Due to Breakage Risk

Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.

Heraeus Medical GmbH
increase of
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Vehicles & Parts
HIGH
NHTSA

Hyundai IONIQ 5 2025 Recall for Rear Suspension Bolts Affects Stability Control

Hyundai recalls 2025 IONIQ 5 EVs for improperly tightened rear suspension alignment adjustment bolts. The issue risks loss of stability control and potentially a crash. Hyundai will repair free of charge, with owner notices mailing November 10, 2025. VINs are searchable on NHTSA.gov as of September 13, 2025.

Hyundai
A loss
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Vehicles & Parts
HIGH
NHTSA

Hyundai Palisade 2025 Seat Belt Buckle Recall Affects 2020-2025 Models

Hyundai Motor America recalls 2020-2025 Palisade SUVs sold through Hyundai dealers. The rear and other seat belt buckles may fail to latch. Owner notification letters are scheduled for November 10, 2025, and dealers will inspect and replace buckle assemblies at no cost.

Hyundai
Seat belt
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls LDL Cholesterol Assay Due to Performance Issues

Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.

Beckman Coulter Ireland
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Philips Azurion Systems Recalled Due to Software Issues

Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nine (9)
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Food & Beverages
HIGH
FDA FOOD

Sam Dry Fruits Pistachio Meats Recalled Due to Salmonella Risk

Sam Dry Fruits & Nuts Enterprises recalled 32,610 pounds of pistachio meats on December 8, 2025. The recall stems from potential Salmonella contamination. Consumers should not consume the product and seek a refund.

Sam Dry Fruits and Nuts Enterprises
Potential contamination
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Health & Personal Care
HIGH
FDA DRUG

ORL Kids Toothpaste Recalled Due to cGMP Deviations

ORL Labs recalled 1,458 containers of ORL Kids Natural Toothpaste, Bubblegum Flavor, on December 8, 2025. The recall follows cGMP deviations that could pose health risks. Consumers should stop using the product immediately.

ORL Labs
cGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

ORL Labs Recalls Kids Mouthwash Over cGMP Deviations

ORL Labs, LLC recalled 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor on December 8, 2025. The recall stems from violations of current Good Manufacturing Practices (cGMP). The product was distributed only in Arizona and poses potential safety risks for children.

ORL Labs
cGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Securitas Healthcare Recalls 900 MHz Call Stations Over Firmware Issue

Securitas Healthcare recalled 5,627 Arial 900 MHz Call Stations on December 8, 2025. A firmware issue may prevent low battery alerts from being transmitted, posing a risk. Affected devices were sold worldwide, including the US and Canada.

Securitas Healthcare
Securitas Healthcare
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Health & Personal Care
HIGH
FDA DEVICE

Securitas Healthcare Recalls 900 MHz Call Station Over Battery Alert Failure

Securitas Healthcare recalled 1,898 units of the Arial 900 MHz Call Station on December 8, 2025. A firmware issue may prevent low battery alerts, posing a risk of battery failure. Users should stop using the device immediately and follow recall instructions.

Securitas Healthcare
Securitas Healthcare
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Food & Beverages
HIGH
FDA FOOD

Keurig Recalls McCafe Decaf Coffee Pods Due to Caffeine Risk

Keurig Green Mountain recalled 960 cartons of McCafe Premium Roast Decaf Coffee K-Cup Pods on December 6, 2025. The product is inaccurately labeled as decaf but may contain caffeine. Consumers in CA, IN, and NV should not consume the pods and seek refunds.

Keurig DR Pepper
Product is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk

Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.

Siemens Medical Solutions USA
A potential
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Health & Personal Care
HIGH
FDA DEVICE

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Beaver-Visitec International
Manufacturing deviation
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Health & Personal Care
HIGH
FDA DEVICE

LimFlow Vector Medical Device Recalled Due to Expiration Date Error

LimFlow recalled 33 units of its Vector model VT-US-23 on December 5, 2025, due to incorrect expiration dates. Patients and healthcare providers should stop using this device immediately. The recall affects distribution across 14 states and the District of Columbia.

LimFlow
Incorrect expiration
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Food & Beverages
HIGH
FDA FOOD

Bharat Bazar Recalls Asafoetida Due to Undeclared Wheat

Bharat Bazar recalled 180 packages of SOMA Kitchen Natural Asafoetida on December 5, 2025, due to undeclared wheat. The product, sold in 4-ounce containers, poses a high risk of allergic reactions for those with wheat allergies. Consumers should stop using the product immediately and contact Bharat Bazar for refunds.

BHARAT BAZAR
Undeclared wheat.
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