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

1,498 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

Olympus Recalls EVIS EXERA II Bronchovideoscope Due to Safety Concerns

Olympus Corporation of the Americas recalled 395 units of the EVIS EXERA II Bronchovideoscope BF Type Q180-AC on September 11, 2025. The recall addresses additional instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA FOOD

Tropicana Brands Group Recalls Apple Juice Over Spoilage Risk

Tropicana Brands Group recalled 1,599 cases of apple juice on September 11, 2025. A manufacturing deviation may cause spoilage or microbial contamination. The affected juice was distributed in 12 states, including Texas and Colorado.

TROPICANA BRANDS GROUP
A manufacturing
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA III Bronchoscope Over Safety Concerns

Olympus Corporation of the Americas recalled 3,046 units of its EVIS EXERA III bronchoscope BF-P190 on September 11, 2025. The recall addresses safety concerns regarding the use of the bronchoscope with laser and high-frequency therapy equipment. Healthcare providers must stop using this device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls Bronchovideoscope BF-1TQ170 Due to Safety Updates

Olympus Corporation of the Americas recalled the Bronchovideoscope BF-1TQ170 on September 11, 2025. The recall affects 2,092 units distributed outside the U.S. Additional instructions for safe use with laser and other therapies prompted this action.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchofiberscope Recalled Over Safety Instructions Update

Olympus Corporation of the Americas recalled 4,289 bronchofiberscopes on September 11, 2025. The recall addresses important updates to the instructions for use when combined with specific medical equipment. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA III Bronchovideoscope Over Safety Hazard

Olympus Corporation of the Americas recalled 5,221 units of the EVIS EXERA III Bronchoscope BF-H190 on September 11, 2025. The recall aims to address safety concerns when used with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Bronchovideoscope Recalled Over Safety Concerns

Olympus Corporation of the Americas recalled the BF-H1100 bronchovideoscope on September 11, 2025, due to safety concerns when used with certain medical equipment. The recall affects 1,867 units distributed outside the U.S. Patients and healthcare providers should stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Boston Scientific Recalls CX Preconnect Pump Over Performance Issues

Boston Scientific recalled one CX Preconnect with TENACIO Pump due to inflation and deflation performance issues. The recall affects models UPN 72404486 and UPN 72404488 distributed in the US and Canada. The recall was issued on September 11, 2025, and remains active as of October 22, 2025.

Boston Scientific
The potential
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HIGHFDA DEVICE

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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HIGHFDA DEVICE

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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HIGHFDA FOOD

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

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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HIGHFDA FOOD

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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HIGHFDA FOOD

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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HIGHFDA FOOD

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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