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 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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HIGHFDA DRUG

MOTRIN 2'S DISP.- 50CT

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

GOLD STAR DISTRIBUTION
CGMP Deviations:
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HIGHFDA DRUG

PEPTO BISMOL 32CT

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

GOLD STAR DISTRIBUTION
CGMP Deviations:
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HIGHFDA DRUG

NYQUIL COLD & FLU -32CT/2PK

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

GOLD STAR DISTRIBUTION
CGMP Deviations:
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HIGHFDA DRUG

Gold Star Distribution Recalls Claritin Over Rodent Contamination

Gold Star Distribution recalled Claritin, 20 Count, on December 26, 2025, due to insanitary conditions resulting from rodent exposure. The recall affects an unknown quantity distributed nationwide. Consumers should stop using the product immediately.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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HIGHFDA DRUG

Gold Star Distribution Recalls PEPCID COMPLETE Over Insanitary Conditions

Gold Star Distribution recalled PEPCID COMPLETE - 25CT on December 26, 2025 due to insanitary conditions, including rodent exposure. The recall affects all lots distributed by Gold Star and poses a high health risk. Consumers should stop using this product immediately and seek guidance from healthcare providers.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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