Drug Recalls Center

1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,355
Total Drug Recalls
11
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

HIGHFDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burning Risk

Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.

Olympus Corporation of the Americas
A deterioration
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HIGHFDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burn Hazard

Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.

Olympus Corporation of the Americas
A deterioration
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HIGHFDA DEVICE

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Large component for the newborn heart rate monitor on January 20, 2023. The recall addresses an incorrect sizing guide that could affect patient safety. This recall impacts distribution in the US and several countries including the UK and UAE.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Surepulse Heart Rate Monitor Cap Recalled for Sizing Error

Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Extra Small component of the VS Newborn Heart Rate Monitor on January 20, 2023. The recall affects devices distributed in the US and several other countries due to an incorrect sizing guide. Consumers must stop using the device immediately and follow manufacturer instructions.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Foundation Medicine Recalls Companion Diagnostic Over Missing Claims Page

Foundation Medicine recalled 59 units of its FoundationOne CDx (F1CDx), RAL-0003 version 31.0 on November 8, 2022. The recall affects devices distributed in the U.S. and internationally due to missing important diagnostic information. Patients and healthcare providers must stop using the device immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
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