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

3,615 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
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues

Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)

GET TESTED INTERNATIONAL AB recalled 16 Food Intolerance Test Medium devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls CONSTRUX Mini Ti Spacer System Over Labeling Issues

Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues

Orthofix U.S. recalled 61,977 units of the CONSTRUX Mini PTC Spacer System on November 3, 2025. The recall impacts various model numbers due to inconsistent labeling claims. Consumers should stop using the product immediately and follow manufacturer instructions for a refund.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls Ti Spacer System Due to Labeling Issues

Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 780G Insulin Pump Recalled Over Software Issue

Medtronic MiniMed recalled 577 units of the MiniMed 780G insulin pump on November 2, 2025. A software flaw in version 6.60 may cause insulin delivery to suspend unexpectedly, posing serious health risks. Patients should stop using the device immediately and follow recall instructions.

Medtronic MiniMed
A software
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Food & Beverages
HIGH
FDA FOOD

Blonde Beard's Dojo Asian Wing Sauce Recalled for Undeclared Soy (2025)

Blonde Beard's recalled 4,888 bottles of Dojo Asian Wing Sauce sold through multiple retailers in the United States and Canada after confirming undeclared soy on the label. The sauce is shelf-stable and packaged in 8-ounce glass bottles. Consumers should not consume the product and should contact Blonde Beard's for refund or replacement.

Blonde Beard's
Undeclared Soy
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Health & Personal Care
HIGH
FDA DEVICE

Aizu Olympus OER-Elite Medical Device Recall Affects 6,578 US Units (2025)

Aizu Olympus recalled 6,578 OER-Elite medical devices distributed nationwide in the United States. The recall cites warnings, cautions, and maintenance requirements and says only trained personnel should perform repairs. Healthcare providers and patients should stop using the device and await recall instructions from the manufacturer.

Aizu Olympus
Inform existing
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MP50 Recall 2025 Over Alarm Failure in 1.9 Million Monitors

Philips North America recalled 1,913,441 IntelliVue MP50 patient monitors worldwide after reports the devices did not alarm. The monitors may fail to alert clinicians to patient deterioration. Hospitals should stop using the devices immediately and follow the manufacturer’s recall instructions.

Philips
Potential issue
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Health & Personal Care
HIGH
FDA DEVICE

PHILIPS IntelliVue MP80 Recall 1,913,441 Monitors Worldwide for Alarm Failure (2025)

Philips North America LLC recalled 1,913,441 IntelliVue MP80 patient monitors distributed worldwide to hospitals after reports the devices did not alarm. The defect could prevent alarms from sounding in critical patient situations. Healthcare facilities should stop using the monitors and follow recall instructions from the manufacturer.

Philips
Potential issue
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue M3002A Recall Over Alarm Failure Affects 1,913,441 Units (2025)

Philips North America LLC recalled 1,913,441 IntelliVue Multi Measurement Server X2 M3002A monitors sold to hospitals and healthcare facilities worldwide after reports the devices could fail to alarm. The defect could delay critical warnings for patients. Healthcare facilities should stop using the devices immediately and follow recall instructions from Philips or their healthcare provider.

Philips
Potential issue
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MX600 Patient Monitor Recall 2025 for Alarm Failure

Philips recalled 1,913,441 IntelliVue MX600 patient monitors distributed worldwide after reports that the devices did not alarm. The defect could prevent alarms that alert clinicians to patient distress. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions from Philips North America LLC.

Philips
Potential issue
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Health & Personal Care
HIGH
FDA DRUG

Nivagen Zinc Oxide Ointment Recalled Due to cGMP Deviations

Nivagen Pharmaceuticals recalled 13,536 containers of zinc oxide ointment on October 31, 2025. The recall follows deviations from current Good Manufacturing Practices (cGMP). Consumers must stop using the product immediately and contact healthcare providers for guidance.

NIVAGEN ZINC OXIDE
cGMP deviations
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound System Recalled Over Compatibility Issues

Philips Ultrasound recalled 4,819 diagnostic ultrasound systems on October 31, 2025. The recall affects models 795005, 795161, and 989605449841 due to compatibility issues with Apple devices running iOS 18. These issues may prevent the systems from performing live imaging, posing risks in medical settings.

Philips Ultrasound
Ultrasound system
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue Patient Monitor MX800 Recalled for Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to alarm, posing a serious risk to patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Philips North America
Potential issue
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