All Product Recalls

Browse through 2,313 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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

Boston Scientific Recalls TENACIO Pump Over Deflation Issues

Boston Scientific recalled 59 units of the TENACIO Pump with InhibiZone on September 11, 2025. The recall addresses potential inflation and deflation performance issues. Patients should stop using the device immediately and follow the manufacturer's instructions.

Boston Scientific
The potential
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA Bronchoscope Over Safety Concerns

Olympus Corporation of the Americas recalled 262 EVIS EXERA bronchoscopes on September 11, 2025. The recall addresses safety issues related to the use of bronchoscopes with laser and coagulation equipment. Healthcare providers and patients must stop using the devices immediately for safety reasons.

Olympus Corporation of the Americas
Additional IFU
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA III Bronchoscope Over Safety Concerns

Olympus Corporation recalled 4,297 EVIS EXERA III bronchoscopes on September 11, 2025. The recall follows updates to the instructions for use regarding safe operation 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

Insulet Recalls Omnipod 5 App Over Insulin Delivery Risks

Insulet recalled 174,013 units of the Omnipod 5 iOS application on September 11, 2025. A software error can lead to the duplication of numbers during manual entry. This increases the risk of insulin overdelivery, potentially causing hypoglycemia.

Insulet
The failure
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HIGHFDA DEVICE

Olympus Recalls EVIS EXERA II Bronchoscope Due to Safety Updates

Olympus Corporation of the Americas recalled 1,473 EVIS EXERA II Bronchoscopes on September 11, 2025. The recall addresses critical updates to the instructions for use when combined with laser and coagulation therapies. Healthcare professionals must stop using the device immediately and follow the manufacturer's instructions.

Olympus Corporation of the Americas
Additional IFU
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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 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 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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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 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 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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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 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 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

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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HIGHFDA DEVICE

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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