cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Medtronic Recalls Stent System Due to Migration Risk

Medtronic recalled its Abre Venous Self-Expanding Stent System on December 4, 2025, due to a potential Nitinol anomaly. This issue may lead to reduced stent diameter and corresponding radial force, increasing the risk of stent migration. The recall affects 442 units distributed worldwide, including the U.S.

Medtronic
Stents may
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Food & Beverages
HIGH
FDA FOOD

AZ Gems Recalls Jumbo Raw Shrimp Over Chloramphenicol Risk

AZ Gems, Inc. recalled 1,099 cases of Jumbo RAW SHRIMP on December 4, 2025, due to elevated chloramphenicol levels. The shrimp, sold under the Member's Mark label, poses a significant health risk. Consumers should not consume the product and seek refunds or replacements immediately.

AZ Gems
elevated levels
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FUFU&GAGA White Wood Frame Queen Size Murphy Wall Bed (unfolded)
MEDIUM
CPSC

FUFU&GAGA Murphy Wall Beds Recalled for 215-Pound Fall Hazard (2025)

Ningbo Tianqi Electronic recalled FUFU&GAGA white wood frame queen-size Murphy wall beds sold at Home Depot and Lowes. The model KF210284US-01MH-A001 may fall during assembly or disassembly. Consumers should stop using the recalled wall beds and contact Ningbo Tianqi Electronic for a full refund.

FUFU&GAGA
During assembly
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Health & Personal Care
HIGH
FDA DEVICE

Mobius Imaging Recalls AIRO CT X-ray Pendant Due to Safety Risk

Mobius Imaging recalled 26 units of the Detachable 10in Pendant Upgrade for the AIRO CT X-ray System on December 4, 2025. The devices lack a critical "Safe Hand Position Warning" label, posing a high risk during operation. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

Mobius Imaging
AIRO pendant
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Health & Personal Care
HIGH
FDA DEVICE

Mobius Imaging Recalls AIRO CT X-ray Pendant Over Safety Label Issue

Mobius Imaging recalled 101 units of the AIRO Computed Tomography X-ray system pendant on December 4, 2025. The pendants lack a critical "Safe Hand Position Warning" label, posing a safety risk for healthcare providers. Users should immediately stop using these devices and follow recall instructions.

Mobius Imaging
AIRO pendant
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical Recalls Vascular Tray Over Detaching Handle Hazard

Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Merit Medical Systems
Inflation device
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical Recalls Inflation Kits Due to Handle Detachment Hazard

Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical Inflation Device Recalled Over Handle Detachment Risk

Merit Medical Systems recalled 4,163,123 inflation devices on December 4, 2025, due to a risk that the handle may detach during use. This defect poses a high hazard to patients and healthcare providers. Consumers should stop using the device immediately and follow the manufacturer’s instructions for returns.

Merit Medical Systems
Inflation device
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalled Ingenia Ambition X MR Systems Over Stiffness Errors

Philips North America recalled 21 Ingenia Ambition X MR systems on December 3, 2025, due to potential stiffness value errors. The recall affects models with software versions R11.1 and R12.1, distributed in the U.S. and worldwide. Healthcare providers must stop using these devices immediately and follow provided instructions.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Philips MR 7700 Systems Recalled Due to Stiffness Value Errors

Philips North America recalled 9 MR 7700 systems on December 3, 2025, due to potential errors in stiffness maps. The recall affects models with software versions R11.1 and R12.1, posing a high hazard risk. Healthcare providers must stop using these devices immediately and follow manufacturer instructions.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Recalls MR Imaging System Over Stiffness Errors

Philips North America recalled three MR imaging systems on December 3, 2025, due to potential stiffness value errors in exported MR Elastography maps. The systems, identified by product code REF: 781270, have software versions R11.1 and R12.1. Users should stop using the devices immediately and contact their healthcare providers for further instructions.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Recalls MR Systems Due to Stiffness Value Errors

Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices immediately and follow recall instructions.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic Recalls Vanta Clinician Programmer Software Over Functionality Issues

Medtronic Neuromodulation recalled 7,123 units of the Vanta Clinician Programmer Application on December 3, 2025. The software may not function as intended, potentially delaying surgical procedures. Healthcare providers and patients must stop using the software immediately.

Medtronic Neuromodulation
Complaints received
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Health & Personal Care
HIGH
FDA DEVICE

Philips MRI System Recalled Due to Stiffness Value Errors

Philips North America recalled 31 MRI systems on December 3, 2025, due to potential errors in stiffness value readings. The affected models include product codes 781358, 782107, and 782136 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Recalls Ingenia 3.0T MR Systems Over High Hazard

Philips North America recalled 24 Ingenia 3.0T MR systems on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed across multiple states and countries. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
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Food & Beverages
HIGH
FDA FOOD

Sysco Recalls Frozen Potato Product Over Hard Plastic Fragments

Sysco Corporation recalled 17,597 cases of frozen potato product on December 3, 2025. The recall affects Sysco Imperial Potato Tater Barrel due to the presence of clear hard plastic fragments. Consumers should not consume this product and seek refunds immediately.

Sysco
Clear hard
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Ingenia Ambition S MR Systems Over Stiffness Errors

Philips North America recalled Ingenia Ambition S MR systems on December 3, 2025, due to stiffness value errors in exported MR Elastography maps. The recall affects one unit distributed in multiple U.S. states and several countries. Users must stop using the device immediately and follow recall instructions.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 Recalls Automated Dispensing Cabinets Over Software Issues

CareFusion 303 recalled 2,079 BD Pyxis ES Enterprise Servers on December 3, 2025 due to a software issue affecting timely updates. The recall impacts devices sold worldwide, including the U.S. and Canada. Patients and healthcare providers must stop using the devices immediately.

CareFusion 303
Due a
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Health & Personal Care
HIGH
FDA DEVICE

Philips Incisive CT Recalled Over Scan Incompletion Risk

Philips Healthcare recalled 35 Incisive CT scanners on December 3, 2025. The devices may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare providers must stop using these devices immediately and follow recall instructions.

Philips Healthcare
Potential for
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    cpsc regulated Recalls | RecallRadar