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

630 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

LeMaitre Vascular Recalls Collagen Vascular Grafts Over Sourcing Issue

LeMaitre Vascular recalled 28 units of Artegraft Collagen Vascular Grafts on September 2, 2025. The recall affects multiple model numbers due to unapproved sourcing of raw materials. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

LeMaitre Vascular
The bovine
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HIGHFDA DEVICE

BigTree Sales Recalls UVC Germicidal Wand Over Radiation Risk

BigTree Sales Inc. recalled a handheld ultraviolet-C germicidal wand on August 29, 2025, due to unsafe levels of UVC radiation. The product can cause skin and eye injuries to users and nearby individuals. Consumers must stop using the device immediately and follow the manufacturer's instructions.

BigTree Sales
The subject
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HIGHFDA DRUG

Fagron Compounds Recalls Bevacizumab Injection Over Sterility Risk

Fagron Compounding Services recalled 109,320 syringes of bevacizumab (Avastin) on August 29, 2025. The recall follows a lack of assurance of sterility, posing a high health risk. Consumers and healthcare providers should stop using the product immediately.

Fagron Compounding Services
Lack of
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HIGHFDA FOOD

I C F Factory Recalls Ice Cream Due to Undeclared Almonds

I C F Factory recalled Vanilla G. Nutt Ice Cream on August 29, 2025, due to undeclared almonds. The recall affects 12 pints distributed in New York. Consumers should not consume the product and should seek a refund.

I C F Factory
May contained
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HIGHFDA DEVICE

Northeast Scientific Recalls Catheter Over Sterility Risk

Northeast Scientific recalled 795 units of its Turbo-Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about breaches in the sterile barrier packaging. This issue compromises the sterility assurance of the device.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheters Over Sterility Risk

Northeast Scientific recalled 173 units of the R-414-151 laser atherectomy catheter on August 29, 2025. The recall stems from potential breaches in the sterile packaging, which could compromise sterility assurance. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 141 units of the 2.0mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall stems from potential breaches in the sterile barrier packaging, risking patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

ImaCor Recalls Miniaturized TEE Probe Due to Assembly Error

ImaCor recalled 45 units of the ClariTEE Miniaturized TEE probe on August 29, 2025, due to a production assembly error. The defect may cause the probe to articulate incorrectly, posing a risk to patient safety. Healthcare providers and patients must stop using the device immediately.

ImaCor
Production assembly
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HIGHFDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 1,019 units of the 1.4mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about potential breaches in the sterile barrier packaging. The product poses a high hazard level due to compromised sterility assurance.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Northeast Scientific Catheter Recalled Due to Sterility Risk

Northeast Scientific recalled 616 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall affects model R-417-156 due to potential breaches in the sterile barrier packaging. This issue compromises sterility assurance, posing a high risk to patients.

Northeast Scientific
Potential for
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HIGHFDA DEVICE

Getinge Recalls 88-Series Washer-Disinfector Due to Overheating Risk

Getinge recalled 788 units of its 88-Series Washer-Disinfector on August 29, 2025. The device may overheat if the circulation pressure calibration is incorrect and the low-pressure alarm fails. This recall affects devices distributed worldwide, including several U.S. states.

Getinge Disinfection Ab
Potential for
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HIGHFDA DEVICE

Fresenius Medical Dialyzer Recalled Over Cap Attachment Issue

Fresenius Medical Care Holdings recalled over 172 million dialyzers on August 29, 2025. The recall affects models with a new cap design that may not securely attach. Healthcare providers and patients must stop using these devices immediately.

Fresenius Medical Care Holdings
To provide
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Recalled Lulive 12-Drawer Dresser (front)
HIGH
CPSC

Lulive Recalls Dressers Due to Tip-Over Risk for Children

Lulive recalled 12,000 dressers on August 28, 2025, due to a serious tip-over hazard. The recalled models are unstable if not anchored to the wall, posing risks of injury or death to children. Consumers should stop using the dressers immediately and seek a full refund.

Lulive
The recalled
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