2,143 recalls tagged with “cpsc regulated”.
GET TESTED INTERNATIONAL AB recalled 50 units of Heavy Metals Test distributed nationwide in the United States. The device was distributed without premarket FDA approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.
GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the manufacturer.
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.
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.
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.
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.
First & Last Tavern recalled 30 cases of Puttanesca Sauce on October 31, 2025. The product may be contaminated with Clostridium botulinum, a toxin that can cause severe illness. Consumers should stop using the sauce immediately and contact the company for a refund.
Philips North America is recalling 1,913,441 IntelliVue MP2 patient monitors worldwide. The devices may fail to alarm when critical conditions arise. Hospitals should stop using the monitors and follow Philips recall instructions.
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.
Blossom Pharmaceuticals recalled 9,600 containers of Lanashield Skin Barrier on October 31, 2025 due to cGMP deviations. Consumers and healthcare providers should stop using the product immediately. The recall affects products distributed nationwide in the USA.
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 LLC is recalling 1,913,441 IntelliVue MP5 patient monitors sold to hospitals worldwide. The devices may fail to alarm, delaying detection of patient distress. Hospitals and clinicians should stop using the monitors immediately and follow Philips recall instructions.
Dynarex Corporation recalled 8,184 bottles of Dynagel Moisturizing Wound Hydrogel on October 31, 2025. The recall follows deviations from current Good Manufacturing Practices (cGMP). Consumers should stop using the product immediately and consult healthcare providers for guidance.
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.
Philips recalls 1.913 million IntelliVue MP20 patient monitors worldwide because the devices may fail to alarm. The issue could prevent critical alerts from sounding. Hospitals should stop using the monitors immediately and follow Philips recall instructions.
Philips North America is recalling 1,913,441 IntelliVue MP60 patient monitors. The monitors may fail to alarm as designed. Hospitals and clinics using MP60 units should stop using the devices and follow the recall instructions.
Dynarex Corporation recalled 2,592 bottles of WeCare Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers and healthcare providers must stop using the ointment immediately and seek guidance.
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.
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.