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

Boston Scientific Recalls TENACIO Pumps Over Inflation Issues

Boston Scientific recalled 172 units of its CXR Preconnect with TENACIO Pump on September 11, 2025. The recall stems from potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada.

Boston Scientific
The potential
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Olympus Recalls Bronchovideoscope Over Safety Instructions Update

Olympus Corporation of the Americas recalled the Bronchovideoscope BF Type P150 on September 11, 2025. The recall affects 1,019 units distributed outside the U.S. This action follows updates to the instructions for use regarding safe operations with laser and high-frequency therapy equipment.

Olympus Corporation of the Americas
Additional IFU
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Abbott Recalls Cardiac Catheter Over Tip Detachment Hazard

Abbott recalled 399 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall stems from a limited number of incidents where catheter tips detached during removal from packaging. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

Abbott
Abbott has
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Abbott Recalls TactiFlex Catheters Due to Tip Detachment Hazard

Abbott recalled 11,805 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall follows reports of tip detachment during catheter removal from packaging. Patients and healthcare providers must stop using the device immediately.

Abbott
Abbott has
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HIGHFDA FOOD

Gina Marie Bakery Recalls Cookies Over Undeclared Ingredients

Gina Marie Bakery recalled 172 cases of Italian Sesame Cookies on September 10, 2025. The recall was initiated due to undeclared sesame and artificial colors. Consumers should not consume these cookies and can seek a refund.

Gina Marie Bakery
Undeclared Sesame,
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Gina Marie Bakery Recalls Cookies Over Undeclared Color Additives

Gina Marie Bakery recalled 172 cases of Vanilla Cookies with Raspberry Peach Jam due to undeclared Red 3 and Blue 1. The recall was initiated on September 10, 2025, after notification to the FDA. Consumers should not consume the product and seek refunds.

Gina Marie Bakery
Undeclared Red
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Gina Marie Bakery Recalls Cookies Over Undeclared Allergens

Gina Marie Bakery recalled 172 cases of Italian Mixed Vanilla Cookies due to undeclared allergens. The recall affects cookies with undeclared almonds, sesame, and artificial colors. Consumers should stop using the product and seek refunds immediately.

Gina Marie Bakery
Undeclared Almonds,
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Abbott Recalls TactiFlex Catheter Due to Tip Detachment Risk

Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters due to potential tip detachment during removal. The recall affects medical devices distributed worldwide. Patients and healthcare providers must stop using the device immediately.

Abbott
Abbott has
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Gina Marie Bakery Recalls Cookies Over Undeclared Dyes

Gina Marie Bakery recalled 172 cases of Vanilla with Apricot Jam Cookies on September 10, 2025. The recall follows the discovery of undeclared Red 40 and Yellow 6 in the product. Consumers should not eat these cookies and seek refunds.

Gina Marie Bakery
Undeclared Red
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Gina Marie Bakery Recalls Cookies Over Undeclared Red 40

Gina Marie Bakery recalled 172 cases of Vanilla Chocolate Dipped Cookies on September 10, 2025. The recall follows the discovery of undeclared Red 40, a potential allergen. Consumers should not consume the cookies and seek refunds immediately.

Gina Marie Bakery
Undeclared
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Gina Marie Bakery Recalls Biscotti Due to Undeclared Red 40

Gina Marie Bakery recalled 172 cases of Toasted Cherry Biscotti on September 10, 2025. The product contains undeclared Red 40, posing a potential health risk. Consumers should not consume the product and are advised to seek a refund or replacement.

Gina Marie Bakery
Contains undeclared
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HIGHFDA FOOD

Goot Essa Cheese Recalled Due to Listeria Contamination

Goot Essa recalled 62 pounds of Der Mutterschaf Cheese on September 10, 2025. A positive Listeria Monocytogenes test prompted the recall. The affected cheese was distributed in Connecticut, New Jersey, Montana, and Virginia.

GOOT ESSA
The firm
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Biomet Recalls Juggerknot Mini Soft Anchors Due to Labeling Error

Biomet recalled 40 units of Juggerknot Mini Soft Anchors on September 9, 2025. The recall stems from a labeling error where the carton contains 1.4mm Short devices instead of the labeled 1.0mm Mini products. Patients and healthcare providers must stop using these devices immediately.

Biomet
The outer
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BioPro Recalls Bipolar Heads Over Sterility Risk

BioPro recalled 147 bipolar heads on September 9, 2025, due to a potential packaging issue. The defect may compromise the sterile barrier, increasing infection risks if implanted. Healthcare providers and patients should stop using these devices immediately.

BioPro
Potential packaging
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BioPro Recalls Endo Heads Due to Sterility Risk

BioPro recalled 147 units of Endo Heads on September 9, 2025. A packaging issue may compromise the sterile barrier, leading to infection risk. Healthcare providers and patients should stop using the devices immediately.

BioPro
Potential packaging
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Eureka Recalls Cinnamon for Elevated Lead Levels

Eureka recalled 32 cases of cinnamon on September 9, 2025, due to elevated lead levels. Consumers should not consume the product and seek refunds. The recall affects retail and wholesale customers in California and Michigan.

EUREKA
Elevated levels
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