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

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 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

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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HIGHFDA FOOD

Whole Foods Market Granola Recalled Due to Allergen Risk

Whole Foods Market recalled Blueberry Almond Granola on September 9, 2025. The product contains undeclared allergens including wheat, sesame, and cashew. Six units, packaged in one-pound containers, were sold at one store in Philadelphia, PA.

WFM Purchasing, LP
Product was
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HIGHFDA DEVICE

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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HIGHFDA DEVICE

BioPro Recalls Femoral Heads Over Sterile Barrier Risk

BioPro recalled 147 femoral heads on September 9, 2025, due to a packaging defect. The defect threatens the sterility of the device, which could lead to infection if implanted. Healthcare providers and patients must stop using these devices immediately.

BioPro
Potential packaging
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HIGHFDA FOOD

Lotsa Pasta Olive Oil Recalled Due to Botulism Risk

Lotsa Pasta International Food Shop recalled 54 bottles of Fresh Basil Infused Olive Oil on September 9, 2025. The product may be contaminated with Clostridium botulinum due to improper manufacturing processes. Consumers should not consume the product and seek a refund or replacement.

Hale
Potential to
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HIGHFDA DEVICE

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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HIGHFDA FOOD

Lee K of NY Recalls Kimchi Mackerel Over Undeclared Allergens

Lee K of NY Inc. recalled 43 units of Aged Kimchi Mackerel on September 8, 2025. The product contains undeclared milk and shrimp, posing a serious allergy risk. Consumers in New York and New Jersey should stop using the product immediately.

Lee K of NY
Product contains
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HIGHFDA DEVICE

Iantrek Recalls Cyclopen Microinterventional System Over Sterility Risk

Iantrek recalled 1,262 units of the Cyclopen Microinterventional Cyclodialysis System on September 6, 2025. The recall stems from a risk of compromised sterile packaging that could affect patient safety. Health care providers and patients must stop using the device immediately and follow manufacturer instructions.

Iantrek
Potential for
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HIGHFDA DEVICE

Iantrek Recalls C-Rex UNO Goniotomy Instrument Over Sterility Risk

Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments on September 6, 2025, due to compromised sterile packaging. The recall affects the model CRX-120 distributed in multiple U.S. states. Healthcare providers and patients must stop using these instruments immediately.

Iantrek
Potential for
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HIGHFDA DRUG

Sandoz Recalls Cyclophosphamide Injection Over Safety Concerns

Sandoz Inc. recalled 263 vials of Cyclophosphamide Injection on September 5, 2025. The recall follows cGMP deviations related to temperature excursions during transportation. Healthcare providers and consumers must stop using the product immediately.

Sandoz
cGMP deviations:
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