2,756 recalls tagged with “immediate action”.
GET TESTED INTERNATIONAL AB's gonorrhea test was distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 13 iodine test devices distributed nationwide in the United States. The devices were distributed 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 recalled 16 Food Intolerance Test Medium devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.
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 recalled 3 Gut Microbiome Test Large kits sold nationwide in the United States after regulators flagged distribution without premarket approval. The recall centers on a lack of FDA clearance for the device. Consumers and healthcare providers should stop using the device immediately and follow recall instructions.
Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.
Get Tested International AB recalled 1,361 HSV-1 and HSV-2 Test Kits distributed nationwide in the United States after regulators found distribution without premarket approval. The test kit lacks FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions by contacting Get Tested International AB.
GET TESTED INTERNATIONAL AB recalled 76 units of its Allergy 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 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 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.
Fresenius Kabi USA recalls 483 LVP Primary Infusion Sets for the IVENIX infusion system nationwide in the United States. The recall cites incorrect assembly of a specific lot. Hospitals and clinicians should stop using the affected sets immediately and follow the manufacturer’s recall instructions.
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 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices immediately.
GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 184 Menopause (FSH) 2 Tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
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.
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.
Nissan North America, Inc. recalls certain 2025 Sentra vehicles. The driver’s seat frame may not be fully secured to the outer side of the seat track, potentially failing to meet FMVSS 207 and 210. Dealers will inspect and replace the driver's side lower seat frame assembly as necessary at no charge; owner letters were mailed May 1, 2025.
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's Mycotoxin Panel Test was recalled after two units were distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.