1,260 recalls tagged with “fda regulated”.
Haagen-Dazs mini chocolate dark chocolate ice cream bars were recalled by Dreyer's Grand Ice Cream and distributed to U.S. retailers. The recall concerns undeclared wheat in the ingredients. Consumers should stop using the product and contact Dreyer's Grand Ice Cream for refunds or replacements.
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 658 parasite tests distributed nationwide in the United States after regulators flagged distribution without premarket approval. The recall, active as of December 2025, targets devices labeled EAN 7340221707153 and SKU A-PARA. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
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 45 intestinal worms test units distributed nationwide in the United States. The action follows distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow the recall 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 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.
GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance
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's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 60 Trichomonas Vaginalis tests distributed nationwide in the United States after regulators found no premarket approval or clearance. The recall stems from a violation of regulatory requirements. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 3 units of its Food Sensitivity Test Large sold nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Consumers should stop using it and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.
GET TESTED INTERNATIONAL AB recalled 6 Gut Microbiome Test Small units 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 the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units 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 manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 8 Fructose Intolerance Test devices distributed nationwide in the United States. The recall cites distribution without FDA 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'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.
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 27 PSA Test devices distributed nationwide in the United States on 2025-11-03 after regulators found the device was distributed without premarket approval or clearance. The lack of PMA/clearance means the device did not receive required regulatory authorization before sale. Patients and healthcare providers should stop using the device immediately and follow 제조
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 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all recall instructions.