305 recalls tagged with “federal law violation”.
GET TESTED INTERNATIONAL AB recalled 528 syphilis tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using them immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 2 Gut Microbiome Test Mega units distributed nationwide in the United States. The recall centers on distribution without premarket approval or clearance. Consumers should stop using the device and contact the manufacturer for instructions. The notice was issued in 2025 and is currently active.
GET TESTED INTERNATIONAL AB recalled 4 Organic acids Test kits distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 100 Kidney Test devices sold nationwide in the United States. The recall cites distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 36 NAD Profile Tests distributed nationwide in the United States after regulators found distribution without premarket approval. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions; contact GET TESTED INTERNATIONAL AB or your health‑ca
GET TESTED INTERNATIONAL AB recalled 10 Vitamin D2 and D3 Test kits distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB recalled 31 Leaky Gut Test devices distributed nationwide in the United States after the product was found to be distributed without FDA premarket approval. The devices test for gut health but lack FDA clearance. Consumers should stop using the device immediately and contact the manufacturer for instructions.
GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET
GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB 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.
GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.
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.
Polaris Industries recalled certain VINs of 2025-2026 Ranger XP 1000 NorthStar and Ranger Crew XP 1000 NorthStar UTVs sold through Polaris dealers nationwide for between $28,000 and $38,000. An improperly routed alternator cable can contact the negative battery post, creating an electrical short and a fire risk. Owners should immediately stop using the recalled vehicles and contact Polaris for a免费
WLIVE expanded its recall to include 16-drawer fabric dressers sold on Amazon. The hazard is tip-over and entrapment risk that can cause serious injury or death to children. Stop using the recalled dressers immediately if not anchored to a wall and contact WLIVE for a full refund.
DINBooonLUX recalled 12-Inch Full-Size Hybrid Mattresses sold on Amazon. The mattresses violate the mandatory flammability standard and pose a risk of serious injury or death in a fire. Stop using the mattress and contact DINBooonLUX for a full refund.
Harppa recalled 5-in-1 convertible high chairs due to risk of serious injury or death from fall and entrapment hazards. The recall involves model BHC001 with production batch 202408. The chairs were sold in green, pink and gray. Consumers should stop using the product immediately and seek a replacement. Harppa provides a replacement option and destruction instructions for the recalled unit.
B Braun Medical Inc. recalls 5,100 IV administration sets distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. The recall cites backflow of medication from piggyback containers into primary IV containers and an occlusion that prevents priming. Patients should stop use immediately and follow recall instructions.
B Braun Medical Inc. recalls 190,625 IV administration sets worldwide, including US and Canada, for risk of backflow from secondary to primary IV containers and occlusion that prevents priming. The recall affects BBMI’s Infusomat Space, Outlook Pump, and Vista Basic Pump compatible sets. Stop-use immediately and follow recall instructions.