These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
Recalled INIU Power Bank – model BI-B41
HIGH
CPSC

INIU Recalls Power Banks Over Fire Hazard

INIU recalled 10,000mAh portable power banks on December 5, 2025, due to fire and burn hazards. The recalled model BI-B41 may overheat and ignite, posing serious risks to consumers. Only certain serial numbers are affected, and users should stop using the product immediately.

Shenzhen Topstar Industry Co., Ltd., of China
The lithium-ion
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HIGHFDA 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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HIGHFDA 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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HIGHFDA FOOD

Evergreen Refreshments Tacos Recalled Due to Foreign Material

Fresh & Ready Foods recalled 200 units of its Evergreen Refreshments brand Ready to Eat Tacos on December 5, 2025. The product may contain foreign material posing a health risk. Consumers should not eat the product and seek a refund.

Fresh & Ready Foods
Foreign material.
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HIGHFDA 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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HIGHFDA 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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Recalled Cubimana Treehouse Building Set
HIGH
CPSC

Cubimana Building Toy Sets Recalled Over Battery Ingestion Risk

Cubimana recalled treehouse building toy sets on December 4, 2025, due to a serious battery ingestion hazard. The recall affects 618 multi-colored pieces that can be easily accessed by children. The sets were sold on Shein for about $20 between July and October 2025.

Cubimana Building Toy Sets
The building
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HIGHFDA DEVICE

Abiomed Recalls Impella 5.5 Devices Due to Packaging Error

Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.

Abiomed
Device packaged
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HIGHFDA 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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Recalled CreateOn Crayola-branded pip-Cubes, Bold Colors 24-Piece, Model 1000199
HIGH
CPSC

CreateOn Recalls Pip-Cubes Over Serious Magnet Ingestion Hazard

CreateOn recalled magnetic pip-Cubes on December 4, 2025, due to a serious ingestion hazard. The recalled sets can pose risks of intestinal blockage or perforation if magnets loosen. Consumers should stop using these products immediately and contact CreateOn for replacements.

CreateOn
The recalled
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Recalled Casaottima 13-Drawer Dresser (front view)
HIGH
CPSC

Casaottima 13-Drawer Dressers Recalled Due to Tip-Over Risk

Casaottima recalled 50,000 13-drawer dressers on December 4, 2025. The dressers pose a serious risk of tip-over and entrapment hazards to children. Consumers should stop using the dressers immediately if unanchored and seek a refund.

Changzhou Municipal Sea Metal Products Co. Ltd., of China
The recalled
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Recalled KTEBO Writing Tablet Toys in Blue/Pink (front)
HIGH
CPSC

KTEBO Writing Tablet Toys Recalled Over Battery Ingestion Hazard

KTEBO recalled its Writing Tablet Toys on December 4, 2025, due to a risk of serious injury or death from battery ingestion. The toys violate mandatory safety standards because the battery compartment screw can detach. Consumers should stop using the toys immediately and seek a replacement.

KTEBO Writing Tablet Toys
The recalled
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HIGHFDA DEVICE

Merit Medical Recalls Inflation Device Due to Detachment Hazard

Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Recalls Custom Manifold Kit Due to Detachment Risk

Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.

Merit Medical Systems
Inflation device
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HIGHFDA 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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HIGHFDA 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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HIGHFDA FOOD

Lil' Turtles Recalls Tomato Basil Soup for Undeclared Milk Allergen

Lil' Turtles recalled 110 cases of Grandma Belle's Tomato Basil Soup on December 4, 2025. The product contains undeclared milk, posing a risk to consumers with milk allergies. Consumers should stop using the soup and contact the manufacturer for a refund.

Lil Turtles
Undeclared allergen
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