federal law violation Recalls

305 recalls tagged with “federal law violation”.

Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Recall: BIOS Battery Causes Startup Failures in Allura Xper CV20 7

Philips Medical Systems Nederland B.V. recalls 53 units of the Allura Xper CV20 system due to a BIOS battery that may deplete faster than designed. The recall affects units distributed worldwide, including the US and many other countries. The failure prevents system startup with no prior warning messages.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Recall Expands for Allura Xper FD20/15 OR Table Model 722059 (2025

Philips Medical Systems Nederland B.V. recalls 8 medical tables worldwide due to BIOS battery depletion risk. The recall affects Allura Xper FD20/15 OR Tables with model number 722059. The BIOS battery may deplete faster than expected, causing the system not to start without warning. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
Read more
Health & Personal Care
HIGH
FDA DEVICE

LeMaitre Vascular Artegraft Collagen Vascular Grafts Recall 2025: 28 U.S. Units Affected

LeMaitre Vascular recalled 28 Artegraft Collagen Vascular Grafts distributed nationwide in 17 states. The grafts use bovine carotid arteries sourced from a supplier not reviewed by the appropriate regulatory authority. Patients and healthcare providers should stop using the device immediately and contact LeMaitre Vascular for instructions.

LeMaitre Vascular
The bovine
Read more
Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter Recall 2026

Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.

Northeast Scientific
Potential for
Read more
Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls 8,368 CLEARLINK CONTINU-FLO IV Sets for Leakage Risk (2025)

Baxter Healthcare recalled 8,368 CLEARLINK SYSTEM CONTINU-FLO IV sets nationwide after reports the devices may leak. The non-vented sets include a 0.2-micron filter, three CLEARLINK luer activated valves and a backcheck valve, and measure 102 inches in length. Hospitals and clinicians should stop using these units immediately and follow Baxter's recall instructions.

Baxter Healthcare
IV sets
Read more
Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Turbo Elite Laser Atherectomy Catheter Recall: 199 Units (2025)

Northeast Scientific recalled 199 units of the NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. The device is not cleared for marketing in the United States. Distribution covered 17 states nationwide, including CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Healthcare providers were advised to stop use immediately.

Northeast Scientific
Potential for
Read more
Health & Personal Care
HIGH
FDA DRUG

Ascend Laboratories Recalls ARIPIPRAZOLE 10 mg Tablets Over Superpotent Drug Risks (2025)

Ascend Laboratories, LLC recalls 2,256 bottles of ARIPIPRAZOLE 10 mg tablets distributed nationwide after discovering the product to be superpotent. The recall involves ARIPIPRAZOLE tablets manufactured by Alken Laboratories Ltd. in India and distributed in the United States. The recall date is August 28, 2025, with consumer notification by letter and guidance to stop use.

ARIPIPRAZOLE
Superpotent drug
Read more
Recalled Lulive 12-Drawer Dresser (front)
HIGH
CPSC

Lulive 12-Drawer Dressers Recalled for Tip-Over Risk in 2025

Lulive recalled 12-drawer dressers sold on Amazon after identifying a risk of serious injury or death from tip-over and entrapment. The dressers are white with a metal frame, a wooden top, 12 collapsing fabric drawers, four side pockets and two hooks. They measure about 12 inches by 39 inches by 45 inches and weigh 30 pounds. Consumers should stop using unanchored dressers immediately and contactL

Lulive
The recalled
Read more
Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Skyra MRI System Recall Covers 182 Units Over Ice Blockage Risk

Siemens Medical Solutions USA recalled 182 MAGNETOM Skyra MRI systems worldwide on August 28, 2025. The recall follows a potential ice blockage in the magnet venting system that could cause a helium leak during a quench. Hospitals should stop using affected devices and follow manufacturer instructions for remediation.

Siemens Medical Solutions USA
There is
Read more
Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Verio Dot Upgrade MRI Recalled Over Ice Blockage Risk (46 Units) 2025

Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot Upgrade MRI systems sold to hospitals worldwide after an ice blockage could prevent venting during a quench. The blockage could cause pressure to build in the helium containment system, potentially rupturing it and releasing helium into the scanning room. Hospitals and providers should stop using the device immediately and follow Siemens

Siemens Medical Solutions USA
There is
Read more
Health & Personal Care
HIGH
FDA DRUG

Chlorpromazine Hydrochloride Tablets Recalled Nationwide for Foreign Substance in Packaging Lot 1022

A high-severity recall covers chlorpromazine hydrochloride tablets distributed nationwide by American Health Packaging. A foreign substance linked to a polyester coil packaging component was detected at the manufacturing site. No tablets were contaminated. Stop using the product and contact the distributor for guidance.

CHLORPROMAZINE HYDROCHLORIDE
Presence of
Read more
Vehicles & Parts
HIGH
NHTSA

Hyundai Recalls 2025-2026 Santa Fe and Tucson for Engine Fastener Issue

Hyundai Motor America is recalling certain 2025-2026 Tucson and Santa Fe vehicles. The connecting rod bolts may have been improperly tightened, which can cause a loss of drive power and engine damage, potentially resulting in an oil leak. Owner notification letters are expected to be mailed October 24, 2025, and dealers will replace the engine free of charge.

Hyundai
A loss
Read more
Health & Personal Care
HIGH
FDA DRUG

AvKare Chlorpromazine Hydrochloride 50 mg Tablets Recalled for Foreign Substance Contamination (2025

AvKare recalled 1,512 cartons of CHLORPROMAZINE HYDROCHLORIDE 50 mg tablets distributed nationwide in the U.S. for the presence of a foreign substance. The recall is active as of Sept. 17, 2025. Consumers and healthcare providers should stop using this product immediately and contact AvKARE or a healthcare provider for guidance.

AvKare
Presence of
Read more
Vehicles & Parts
HIGH
NHTSA

Kia 2025 K4 and Sorento Recalled for Engine Fasteners SC349

Kia America, Inc. recalls 2025 K4 and Sorento vehicles at Kia dealerships after finding the connecting rod bolts may have been improperly tightened. The defect can cause a loss of drive power, increasing the risk of a crash. Owner notification letters are scheduled to be mailed September 12, 2025, and dealers will replace the sub engine assembly at no charge.

Kia
A loss
Read more
Health & Personal Care
HIGH
FDA DEVICE

CooperVision Recalls 180 Softmed Breathables Toric Lenses Over Invalid Sterilization Cycle (2025)

CooperVision recalled 180 Softmed Breathables toric daily disposable contact lenses after one lot was manufactured with an invalid sterilization cycle. The lenses were distributed across Florida, Kentucky, North Carolina and Wisconsin. Patients should stop using the affected lenses immediately and follow the recall instructions.

CooperVision
One lot
Read more
Vehicles & Parts
HIGH
NHTSA

Ford Recalls 2025 Explorer and Aviator for Trailer Tail Light Failure (25C42)

Ford recalls 2025 Explorer and Aviator vehicles sold through Ford dealers due to a faulty body control module that can prevent trailer tail lights from illuminating. The defect may reduce visibility for other drivers when towing a trailer. Interim letters alert owners starting Oct 13, 2025, with a final remedy anticipated in April 2026. Ford will perform the repairs at no charge and provide the an

Ford
Trailer tail
Read more
Health & Personal Care
HIGH
FDA DEVICE

Abbott Point Of Care i-STAT EG7+ Cartridges Recalled Over 6.1 Million Units in 2025

Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.

Abbott Point Of Care
Lack of
Read more
    federal law violation Recalls | RecallRadar