689 recalls tagged with “fda regulated”.
GET TESTED INTERNATIONAL AB recalled 15 units of its Lactose Intolerance Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer instructions.
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 recalled two units of its Gut Microbiome Test on November 3, 2025. The recall stems from distribution without necessary premarket approval or clearance. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 12 units of the Serotonin Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
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 recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.
Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.
GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 148 units of its Diabetes HbA1c Test on November 3, 2025. The recall stems from distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
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.
Philips North America LLC is recalling 1,913,441 IntelliVue MX700 patient monitors (Product Number 865241) distributed worldwide. The monitors may fail to alarm. Hospitals and clinicians should stop using the affected devices immediately and follow the recall instructions.
Stryker recalled 289 Arise 1000EX mattresses on October 31, 2025. The recall affects products sold nationwide due to potential incompatibility with MV3 beds. Users should stop using these mattresses immediately.
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.
Cipla USA recalled 4,438 cartons of Phytonadione Injectable Emulsion on October 31, 2025. The product failed stability specifications, raising concerns about its safety. Consumers and healthcare providers must stop using the product immediately and seek guidance.
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.
Nivagen Zinc Oxide Ointment 20% skin protectant, manufactured in India for Nivagen Pharmaceuticals and distributed nationwide in the USA, is recalled. The recall covers 912 containers. The defect cited is cGMP deviations. Consumers and healthcare providers should stop using the product and follow guidance from Blossom Pharmaceuticals or a healthcare professional.
B Braun Medical recalled 100 IV administration sets on October 29, 2025, due to a backflow risk. The recall affects gravity IV and pump administration sets used with several infusion pumps. The potential for medication backflow poses a serious health risk to patients.
B Braun Medical recalled 9,500 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used in conjunction with the Infusomat Space, Outlook, and Vista Basic pumps. Healthcare providers and patients must stop using these devices immediately to avoid serious health risks.