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

2,324 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 FOOD

Island Crab Recalls Smoked Grouper Dip Over Allergen Risks

Island Crab Corporation recalled 23 units of Smoked Grouper Dip on January 8, 2026. The product contains undeclared allergens including milk, eggs, and sodium metabisulfite. Consumers should not consume this product and seek a refund.

ISLAND CRAB
Undeclared Milk,
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HIGHFDA DEVICE

Medline Dialysis Kits Recalled Over Silicone Seal Issues

Medline Industries recalled 14,525 dialysis convenience kits on January 8, 2026. The recall affects multiple product SKUs due to potential silicone seal failures. These issues may cause therapy delays or exposure to contaminants.

Medline Industries, LP
Affected lots
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HIGHFDA DEVICE

Medline Recalls Tego Connectors Over High Risk of Fluid Leakage

Medline Industries recalled 1,212 kits containing Tego Connectors on January 8, 2026. The recall stems from issues with silicone seals that may cause occluded fluid paths. Users may experience delays in therapy or exposure to contaminants due to this defect.

Medline Industries, LP
Affected lots
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to High Hazard Risk

Medline Industries recalled 516 medical kits on January 8, 2026, due to issues with Tego Connectors. The silicone seal may tear or dome, posing a high risk of therapy interruption and exposure to contaminants. Healthcare providers must stop using these devices immediately and follow recall instructions.

Medline Industries, LP
Affected lots
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HIGHFDA DEVICE

Medline Dialysis Kits Recalled Over Risk of Fluid Leakage

Medline Industries recalled 2,020 dialysis kits on January 8, 2026, due to defective silicone seals. The seals may dome or tear, leading to fluid leaks and contamination. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
Affected lots
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HIGHFDA DEVICE

Medline Recalls Dialysis Dressing Change Kits Over High Hazard

Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.

Medline Industries, LP
Affected lots
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Over Sterility Concerns

Medline Industries recalled 15 units of its Triple Lumen Insertion Kits on January 7, 2026. The recall stems from calibration issues in sterilization equipment that may affect the product's sterility assurance level. Users should cease use immediately and follow manufacturer instructions.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Medline Drape Pack Recalled Over Sterility Concerns

Medline Industries recalled 72 units of Drape Pack-Choice, Model DYNJ63118A, on January 7, 2026. Calibration issues in sterilization equipment may compromise product sterility. Patients and healthcare providers should stop using the device immediately.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Medline Surgical Kits Recalled Over Sterility Concerns

Medline Industries recalled 82,597 surgical kits on January 7, 2026, due to issues with sterilization calibration. The defect may compromise sterility assurance levels of the products. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Medline PPE Kits Recalled Due to Sterilization Issues

Medline Industries recalled 7,575 PPE kits on January 7, 2026, due to calibration problems affecting sterilization. The recall involves model number DYK1011945P, distributed worldwide. Users should stop using the affected kits immediately and follow manufacturer instructions.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Medline Recalls Surgical Gowns Due to Sterility Risk

Medline Industries, LP recalled over 70 million surgical gowns on January 7, 2026, due to sterilization calibration issues. These issues may compromise the sterility assurance level of the gowns, posing a potential health risk. Healthcare providers and patients should stop using these gowns immediately and follow the recall instructions.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Medline Recalls Surgical Convenience Kits Over Sterility Issues

Medline Industries recalled 39,315 surgical convenience kits on January 7, 2026. Calibration issues in sterilization equipment may compromise the sterility of these devices. Healthcare providers and patients should stop using these products immediately.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risks

Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.

Olympus Corporation of the Americas
Devices which
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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 136,037 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients must stop using the devices immediately.

Olympus Corporation of the Americas
Devices which
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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Over Risk of Deformation

Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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HIGHFDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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HIGHFDA DEVICE

Olympus Recalls Sphincterotome V Due to Deformation Risk

Olympus Corporation of the Americas recalled 30,489 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall stems from devices that failed to undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Devices which
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HIGHFDA DEVICE

Olympus Medical Device Recalled Over Deformation Risk

Olympus Corporation recalled 4,183 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices may deform and lose performance due to inadequate thermoforming. Healthcare providers should immediately stop using the affected products and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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