185 recalls tagged with “federal law violation”.
GET TESTED INTERNATIONAL AB recalled 1,361 herpes tests 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 1,218 D-Dimer Tests on November 3, 2025, due to distribution without premarket approval. The recall affects units distributed nationwide in the U.S. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 12 units of its Peptic Ulcer Test on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States.
GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the test immediately.
GET TESTED INTERNATIONAL AB recalled 24 Akkermansia Tests 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 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled six units of its Gut Microbiome Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 55 SIBO Test units on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled one GI Microbiome Profile Small on November 3, 2025. The recall stems from distribution without premarket approval. This recall affects healthcare providers and patients across the United States.
GET TESTED INTERNATIONAL AB recalled 940 Lyme tests on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients must stop using the product immediately.
GET TESTED INTERNATIONAL AB recalled five Chlamydia Tests on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
Fresenius Kabi USA recalled 12,075 infusion pump administration sets on November 3, 2025. The recall stems from incorrect assembly that poses a serious risk of patient injury. Healthcare providers and patients should stop using the devices immediately.
GET TESTED INTERNATIONAL AB recalled three units of its Gut Microbiome Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Consumers and healthcare providers should stop using the product immediately.
Philips North America recalled 1,913,441 IntelliVue MP80 monitors on October 31, 2025. The devices may fail to alarm, presenting a high risk to patient safety. Healthcare providers and patients should stop using the monitors immediately.
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.
WLIVE expanded its recall of 16-drawer dressers on October 30, 2025. Consumers reported serious injury risks due to instability if not anchored. The dressers violate safety standards and pose hazards to children.
YaFiti recalled its Fabric 12-Drawer Dressers on October 30, 2025, due to tip-over and entrapment risks. The dressers can pose serious injury or death risks, especially to children, if not anchored to the wall. Consumers should stop using the product immediately and return it for a full refund.
Crate & Barrel recalled Ana Dining Chairs on October 30, 2025, after reports of leg failures. The chairs pose a fall hazard, affecting models sold from January 2021 to January 2025. Consumers should stop using these chairs immediately and contact the company for a replacement.
B Braun Medical recalled 960 IV administration sets on October 29, 2025. The recall affects sets used with Infusomat Space, Outlook, and Vista pumps. Users face a high risk of medication backflow and occlusion.
B Braun Medical recalled 6,768 IV administration sets on October 29, 2025. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. The recall addresses a potential backflow issue that could compromise patient safety.