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

1,488 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

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

Baxter Healthcare Recalls IV Infusion Sets Due to Leak Risk

Baxter Healthcare recalled 27,072 IV infusion sets on August 29, 2025, due to potential leaks. The affected product, model code 2R8858, may pose significant risks to patients. Healthcare providers and patients should stop using these devices immediately.

Baxter Healthcare
IV sets
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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

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 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

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 FOOD

Rolling Pin Chocolate Recalled Over Undeclared Wheat Allergen

Rolling Pin Baking Company recalled 127,680 units of chocolate on August 29, 2025. The product contains wheat, which is not declared in the allergen statement. Consumers should not consume the product and seek a refund.

ROLLING PIN BAKING COMPANY
Product does
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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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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 49,200 IV solution sets on August 29, 2025. The recall affects products that may leak, posing a risk to patients. Healthcare providers and patients should stop using these devices immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Extension Sets Due to Leakage Risk

Baxter Healthcare recalled 2,304 Clearlink System Extension Sets on August 29, 2025, due to potential leakage. The recall affects IV sets distributed nationwide across multiple states. Healthcare providers and patients should stop using the device immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

ConvaTec Recalls DuoDERM Dressings Over Foreign Matter Hazard

ConvaTec recalled 80,980 DuoDERM Extra Thin dressings on August 29, 2025, due to potential foreign matter contamination. The dressing is designed for dry to lightly exudating wounds and is suitable for use on sensitive areas. Patients should stop using the product immediately and follow the recall instructions provided by the manufacturer.

ConvaTec
Wound dressing
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HIGHFDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 1,167,120 units of its CLEARLINK SYSTEM CONTINU-FLO Solution Set on August 29, 2025. The recall affects IV sets due to a risk of leakage that could pose serious health risks. Patients and healthcare providers should stop using these devices immediately.

Baxter Healthcare
IV sets
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