cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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 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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Health & Personal Care
HIGH
FDA DEVICE

STRYKER NICO Myriad Handpiece Recall for 39,148 Units Worldwide (2026)

STRYKER recalled 39,148 NICO Myriad Handpieces sold worldwide due to latex in packaging that could trigger allergic reactions. The latex-containing tape secures components within packaging. Healthcare providers and patients should stop using the device immediately and follow the recall instructions from Stryker.

Stryker
Tape used
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MX100 Patient Monitors Recalled for Alarm Failure (Z-0861-2026)

Philips North America recalled 1,913,441 IntelliVue MX100 patient monitors due to potential alarm failure. The recall is active as of December 2025. The manufacturer warns patients and healthcare providers to stop using affected devices and follow recall instructions. Contact Philips North America LLC for guidance.

Philips North America
Potential issue
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Health & Personal Care
HIGH
FDA DRUG

Trifecta Pharmaceuticals Recalls Zinc Oxide Ointment Due to cGMP Deviations

Trifecta Pharmaceuticals recalled 33,000 containers of Globe Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. Consumers should stop using the product immediately to avoid potential risks. Healthcare providers are advised to contact the company for further guidance.

ZINC OXIDE 20%
cGMP deviations
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DRUG

Trifecta Pharmaceuticals Recalls Clotrimazole Cream Over cGMP Issues

Trifecta Pharmaceuticals recalled 14,700 bottles of Globe Clotrimazole Cream USP on October 31, 2025, due to significant cGMP deviations. The affected product may not meet necessary safety and quality standards. Consumers should stop using the cream immediately and seek guidance from healthcare providers.

CLOTRIMAZOLE
cGMP deviations
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MP90 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP90 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Users must stop using the devices immediately and follow manufacturer instructions for remedy.

Philips North America
Potential issue
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MP30 Monitors Recalled for Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP30 monitors on October 31, 2025. The devices may fail to alarm, posing a serious risk to patients. Users must stop using the monitors and follow recall instructions immediately.

Philips North America
Potential issue
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Health & Personal Care
HIGH
FDA 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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