All Product Recalls

Browse through 2,317 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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 DEVICE

GET TESTED INTERNATIONAL AB Recalls Fructose Intolerance Test

GET TESTED INTERNATIONAL AB recalled eight units of the Fructose Intolerance Test on November 3, 2025. The recall occurs due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Intestinal Worms Test

GET TESTED INTERNATIONAL AB recalled 45 units of its Intestinal Worms Test on November 3, 2025. The recall stems from distribution without necessary premarket approval or clearance. Healthcare providers and patients must stop using the product immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Heavy Metals Test for Approval Issues

GET TESTED INTERNATIONAL AB recalled 50 units of its Heavy Metals Test on November 3, 2025. The recall follows distribution without premarket approval or clearance, posing potential health risks. Healthcare providers and patients must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Adrenal Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls MPOX Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled four MPOX Test units on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Gonorrhea Test Recall

GET TESTED INTERNATIONAL AB recalled 463 gonorrhea tests on November 3, 2025. The recall follows distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA 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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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 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 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
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