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
HIGHFDA DEVICE

AGFA Recalls Digital Radiography X-Ray System Over Radiation Risk

AGFA Healthcare recalled 35 Digital Radiography X-Ray systems on November 18, 2025, due to a risk of exceeding safe radiation levels. The recall affects systems distributed nationwide in the U.S. Users must stop using the device immediately and follow manufacturer instructions.

AGFA Healthcare
It is
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HIGHFDA DEVICE

Sheathing Technologies Recalls Ultrasound Probe Covers Over Infection Risk

Sheathing Technologies recalled 12 units of its ultrasound probe covers on November 17, 2025, due to potential contamination risks. The non-sterile vaginal and rectal covers may have defects that pose an infection risk during use. Consumers should stop using the product immediately and follow the manufacturer's instructions.

Sheathing Technologies
Vaginal/rectal ultrasound
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HIGHFDA DEVICE

Sophysa Recalls Pressio 2 ICP Monitoring System Due to Rebooting Hazard

Sophysa recalled 105 units of the Pressio 2 ICP Monitoring System on November 17, 2025, after receiving customer complaints regarding unexpected rebooting. This defect poses a high risk for patients relying on the device for monitoring intracranial pressure. Users should stop using the device immediately and follow the manufacturer's instructions.

Sophysa
Customer complaints
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HIGHFDA DEVICE

ETAC A/S Recalls Molift 4-Point Sling Bars Over Safety Hazard

ETAC A/S recalled 25 units of the Molift 4-point sling bars on November 17, 2025, due to a defect that can lead to improper functionality. The issue stems from a bolt that may break during assembly and load testing, posing a high risk during use. This recall affects products distributed worldwide, including the United States and several European countries.

ETAC A/S
A customer
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HIGHFDA DEVICE

Molift Recalls 2-Point Sling Bars Due to High Injury Risk

ETAC A/S recalled 64 units of Molift 2-point sling bars on November 17, 2025. A defect in the mounting bolt can lead to failure during use. This poses serious risks for users relying on the device for mobility assistance.

ETAC A/S
A customer
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HIGHFDA DEVICE

Molift Recalls Mover 300 Hoists Over Bolt Failure Risk

Molift recalled 71 Mover 300 mobile hoists on November 17, 2025, due to a potential bolt failure. The defect can lead to limited mobility, posing a high risk to users. Affected models include M1501, M1502, M1504, among others.

ETAC A/S
A customer
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HIGHFDA DEVICE

ETAC A/S Recalls Molift Mover 205 Over High Injury Risk

ETAC A/S recalled 95 Molift Mover 205 devices due to a serious defect. The lifting bar bolt can break during use, posing a high risk of injury. Customers should stop using the product immediately and contact the company for further instructions.

ETAC A/S
A customer
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HIGHFDA FOOD

Prime Food Processing Recalls Lava Bun Over Undeclared Milk Hazard

Prime Food Processing recalled 2,243 cases of Lava Bun with Green Tea Flavor on November 16, 2025. The product does not declare milk in its ingredient statement, posing a risk to consumers with milk allergies. The recall affects 16 states including California, Texas, and Florida.

Prime Food Processing
Products do
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HIGHFDA FOOD

Prime Food Processing Recalls Lava Buns Over Undeclared Milk

Prime Food Processing LLC recalled 2,243 cases of Lava Buns with Salted Egg Yolk on November 16, 2025. The recall occurred due to undeclared milk in the product's ingredient statement. This poses a high risk to individuals with milk allergies.

Prime Food Processing
Products do
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HIGHFDA DRUG

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk

Cipla USA recalled 12,576 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025, due to a nitrosamine impurity. The impurity, N-nitroso-cinacalcet, exceeds acceptable daily intake limits. Consumers must stop using this product immediately and contact healthcare providers for guidance.

CINACALCET
CGMP Deviations:
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HIGHFDA DRUG

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Nitrosamine Hazard

Cipla USA, Inc. recalled 15,744 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall follows the discovery of a nitrosamine impurity exceeding acceptable daily intake limits. Consumers should stop using the product immediately and consult healthcare providers.

CINACALCET
CGMP Deviations:
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HIGHFDA DRUG

Cipla Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk

Cipla USA, Inc. recalled 63,504 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall results from a nitrosamine impurity, N-nitroso-cinacalcet, exceeding acceptable daily intake limits. Consumers should stop using the tablets immediately and contact healthcare providers for guidance.

CINACALCET
CGMP Deviations:
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HIGHFDA FOOD

Venzu Traders Recalls Cinnamon Powder Over Lead Contamination

Venzu Traders LLC recalled 24 cases of cinnamon powder on November 14, 2025, due to potential lead contamination. The affected product weighs 3.5 ounces and is sold under UPC 7 46241 29537 8. Consumers should stop using this product immediately and contact the distributor for a refund.

VENZU TRADERS
Potential contamination
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Recalled Zigjoy Toddler Sleep Sack with Feet – Excavator print
HIGH
CPSC

Zigjoy Recalls Children's Sleep Sacks Due to Burn Hazard

Zigjoy recalled children's sleep sacks on November 13, 2025, after discovering a violation of mandatory flammability standards. The recall affects sleep sacks sold in blue and pink, posing a serious burn risk to children. Consumers should stop using the sleep sacks immediately and contact Zigjoy for a refund.

Zigjoy Sleep Sacks with Feet
The recalled
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Recalled CR2032 Lithium Coin Batteries, Item 00263
HIGH
CPSC

Great Lakes Select Battery Packs Recalled Over Ingestion Risk

Great Lakes Wholesale International recalled select battery packs on November 13, 2025. The battery packs lack child-resistant packaging and pose a serious ingestion risk for children. Consumers should stop using the products immediately and seek refunds.

Great Lakes Wholesale International
The button
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Recalled Bettina Doll Set with Magic Light Unicorn
HIGH
CPSC

Bettina Doll Sets Recalled Due to Battery Ingestion Hazard

Bettina Doll Sets with Magic Light Unicorn recalled on November 13, 2025, after reports of battery ingestion risks. The unicorn's battery compartment is accessible to children. The recall affects all units sold on Amazon by Shantou Chenghai Xingzigu Toy Industry.

Bettina Doll Sets
The doll
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