All Product Recalls

Browse through 1,551 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA FOOD

Dreyer's Grand Ice Cream Recalls Haagen-Dazs Bars Over Undeclared Wheat

Dreyer's Grand Ice Cream recalled 3,410 cases of Haagen-Dazs mini chocolate dark chocolate ice cream bars on November 3, 2025. The recall occurred due to undeclared wheat, which poses a serious health risk to individuals with wheat allergies. The affected products were distributed in California, Kentucky, Ohio, and Wisconsin.

Dreyer's Grand Ice Cream
Undeclared wheat.
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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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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 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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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
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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 DEVICE

Stryker Recalls NICO Myriad Handpieces Over Latex Allergy Risk

Stryker recalled 39,148 NICO Myriad Handpieces on October 31, 2025, due to a latex hazard. The packaging tape contains latex despite products being labeled latex-free. This poses a significant allergy risk to patients and healthcare providers.

Stryker
Tape used
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HIGHFDA DEVICE

Philips Patient Monitor Recalled Over Alarm Malfunction

Philips North America recalled over 1.9 million IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to sound alarms, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.

Philips North America
Potential issue
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HIGHFDA FOOD

Blonde Beard's Wing Sauce Recalled Due to Undeclared Soy

Blonde Beard's recalled 4,888 bottles of Dojo Asian Wing Sauce on October 31, 2025. The product contains undeclared soy, posing a risk to individuals with soy allergies. The sauce was distributed across multiple states and Canada.

Blonde Beard's
Undeclared Soy
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HIGHFDA DEVICE

Philips Recalling IntelliVue Patient Monitors Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. A potential issue causes the monitors to fail to alarm, posing serious risks to patient safety. Consumers and healthcare providers should stop using these devices immediately and follow recall instructions.

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
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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

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

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

Dynashield Cream Recalled Due to cGMP Deviations

Dynashield, a 4 oz cream, is recalled after cGMP deviations were identified. The recall affects 7,944 units distributed nationwide. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

DYNASHIELD
cGMP deviations
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