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

Stryker Recalls BrainPath Devices Over Latex Allergy Risk

Stryker Corporation recalled 39,148 BrainPath devices on October 31, 2025, due to a latex allergy risk. The tape used to secure components contains latex, despite being labeled latex-free. This recall affects devices distributed worldwide, including the U.S. and multiple countries.

Stryker
Tape used
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HIGHFDA DRUG

Dynarex Recalls Wecare Enema Due to Safety Violations

Dynarex Corporation recalled 18,912 containers of Wecare Enema on October 31, 2025, due to cGMP deviations. Consumers should stop using the product immediately. The recall affects products distributed nationwide in the USA.

SALINE ENEMA
cGMP deviations
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HIGHFDA 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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HIGHFDA DEVICE

Philips Recalls IntelliVue MP2 Monitors Due to Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP2 monitors on October 31, 2025. The monitors may not alarm as intended, posing a risk to patient safety. Affected devices were distributed worldwide, including the United States and multiple countries.

Philips North America
Potential issue
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HIGHFDA DEVICE

Philips Recalls IntelliVue MP20 Monitors Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP20 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Philips North America
Potential issue
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HIGHFDA DEVICE

Stryker MV3 Bariatric Bed Recalled Over Compatibility Issues

Stryker Medical recalled 286 MV3 bariatric beds on October 31, 2025. The beds may not be compatible with Arise 1000EX mattresses, posing risks to patients. Healthcare providers and patients must stop using the beds immediately.

Stryker Medical Division of Stryker
Stryker has
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HIGHFDA FOOD

First & Last Tavern Marinara Sauce Recalled Over Botulism Risk

First & Last Tavern recalled 30 cases of marinara sauce on October 31, 2025. The sauce may be contaminated with Clostridium botulinum, posing a high health risk. Consumers should not consume the product and seek refunds or replacements.

First & Last Tavern
May be
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HIGHFDA DEVICE

Philips IntelliVue MP50 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP50 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Healthcare providers must stop using the devices immediately and follow recall instructions.

Philips North America
Potential issue
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HIGHFDA DEVICE

Philips IntelliVue MP40 Monitors Recalled Over Alarm Failure

Philips recalled 1,913,441 IntelliVue MP40 monitors on October 31, 2025, due to a failure to alarm. This defect poses a high risk to patient safety. The recall affects devices distributed worldwide, including in the US.

Philips North America
Potential issue
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HIGHFDA DEVICE

Philips IntelliVue MP60 Recalled Over Alarm Malfunction Risk

Philips North America recalled 1,913,441 IntelliVue MP60 monitors on October 31, 2025. The monitors may fail to alarm, posing a significant risk to patient safety. Affected devices were distributed worldwide, including the United States and multiple countries.

Philips North America
Potential issue
Read more
HIGHFDA DEVICE

Philips IntelliVue Monitor Recalled Due to Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Multi Measurement Servers on October 31, 2025. These devices may fail to alarm, posing a serious risk to patient safety. Users should stop using the device immediately and follow recall instructions.

Philips North America
Potential issue
Read more
HIGHFDA DEVICE

Philips IntelliVue MP5 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP5 monitors on October 31, 2025, due to a failure to alarm. The recall affects devices distributed worldwide, including the United States. Patients and healthcare providers must stop using the monitors immediately.

Philips North America
Potential issue
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HIGHFDA DEVICE

Aizu Olympus Recalls OER-Elite Medical Device Over Safety Hazards

Aizu Olympus recalled 6,578 OER-Elite medical devices following safety concerns. The recall, announced on October 31, 2025, urges patients and healthcare providers to stop using the device immediately. Repairs should only be conducted by trained personnel to ensure safety.

Aizu Olympus Co.
Inform existing
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HIGHFDA DRUG

Dynashield Skin Protectant Recalled for cGMP Violations

Dyrnarex Corporation recalled 1,560 containers of Dynashield Skin Protectant on October 31, 2025. The product may not meet current Good Manufacturing Practice standards. Consumers should stop using the product immediately and seek guidance from healthcare providers.

DYNASHIELD
cGMP deviations
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HIGHFDA DRUG

Dynarex Recalls Wecare Calasoothe Ointment Over cGMP Violations

Dynarex Corporation recalled 2,400 containers of Wecare Calasoothe on October 31, 2025, due to cGMP deviations. The recall affects the 4 oz ointment, as it may not meet safety standards. Consumers should stop using the product immediately and consult their healthcare providers.

MENTHOL AND ZINC OXIDE
cGMP deviations
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HIGHFDA 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
Read more
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