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

2,247 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

Alphatec Spine Recalls Surgical Instruments Over Connection Issue

Alphatec Spine recalled 7 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The incorrect navigated array connection geometry poses a high hazard risk in surgical settings. Healthcare providers and patients must stop using the devices immediately.

Alphatec Spine
Due a
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HIGHFDA DEVICE

Medline Industries Recalls IV Administration Sets Due to Leakage Risk

Medline Industries recalled over 926,000 IV Administration and Extension Sets due to a significant risk of leaks and breaks. The recall affects multiple models with potential exposure to chemicals and mechanical forces. Users should discontinue use immediately to prevent serious health risks including blood loss and infections.

Medline Industries, LP
Under circumstances
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HIGHFDA FOOD

WFM Purchasing Recalls Brussel Sprouts & Kale Slaw Over Allergen Risk

WFM Purchasing, LP recalled 88 units of Brussel Sprouts & Kale Slaw on December 31, 2025. The product contains undeclared fish and egg allergens, posing a serious health risk. Consumers in New York, New Jersey, and Virginia should not consume this product.

WFM Purchasing, LP
Undeclared Fish
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HIGHFDA DRUG

Alvogen Recalls Levothyroxine Sodium Tablets Due to Mix-Up

Alvogen, Inc. recalled Levothyroxine Sodium Tablets on January 21, 2026, after a pharmacy reported a mix-up with dosages. Some bottles contained 88 mcg tablets instead of the prescribed 150 mcg. The recall affects 1,000 tablets from lot # MHA21825, with an expiration date of December 31, 2027.

LEVOTHYROXINE SODIUM
Product Mix-Up:
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HIGHFDA DEVICE

Miach Orthopaedics Recalls BEAR Implant Over Expiration Date Error

Miach Orthopaedics recalled 284 units of the BEAR Implant, Model Number 1000, on December 31, 2025. The recall stems from an incorrect expiration date on the label that exceeds the product's approved shelf life. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Miach Orthopaedics
Incorrect expiration
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HIGHFDA DEVICE

Medica Recalls Capillary Tube Kit Over False Potassium Readings

Medica recalled 1,578 units of its Capillary Tubes on December 31, 2025. A systematic positive bias of up to 20% can produce false elevation results in patient potassium levels. Healthcare providers and patients must stop using the device immediately.

Medica
A systematic
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HIGHFDA DRUG

Zydus Pharmaceuticals Recalls Icosapent Ethyl Capsules Over Subpotency

Zydus Pharmaceuticals recalled 22,896 bottles of Icosapent Ethyl capsules on December 30, 2025. The recall stems from leakage and oxidation that may reduce the drug's effectiveness. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Subpotent Drug:
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Ondansetron Tablets Over Packaging Issues

Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.

ONDANSETRON
Defective container:
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HIGHFDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Display Over High Injury Risk

Intuitive Surgical recalled 47 da Vinci 5 Surgeon Console Viewer Displays on December 30, 2025. The devices may lose display functionality, risking surgical injury. Healthcare providers should stop using the consoles immediately and follow recall instructions.

Intuitive Surgical
Robotic-assisted surgical
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HIGHFDA DEVICE

Siemens X-Ray System Recalled Due to Image Processing Errors

Siemens Medical Solutions USA recalled five LUMINOS Q.namix T X-ray systems on December 29, 2025. The recall affects devices that can process images from previous patients due to a software issue. Healthcare providers must stop using these devices immediately.

Siemens Medical Solutions USA
Ortho images
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HIGHFDA DEVICE

Siemens Recalls Interventional Fluoroscopic X-Ray System Over Imaging Risk

Siemens Medical Solutions USA recalled 40 units of its LUMINOS Q.namix R X-ray system on December 29, 2025. The recall addresses a defect that may result in images being incorrectly processed, potentially showing images from previous patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Siemens Medical Solutions USA
Ortho images
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HIGHFDA DEVICE

Cerapedics Recalls Bone Graft Due to Incorrect Expiration Date

Cerapedics recalled 237 units of PearMatrix P-15 Peptide Enhanced Bone Graft on December 29, 2025. The recall affects products distributed nationwide after a review revealed incorrect expiration dates. Patients and healthcare providers should stop using the product immediately.

Cerapedics
Incorrect expiration
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HIGHFDA DRUG

EXCEDRIN MIGRAINE 2'S- 25 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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HIGHFDA DRUG

Aleve 1's, 60 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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