Browse through 2,959 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.
GET TESTED INTERNATIONAL AB recalled 40 units of its Urinary Tract Infection 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 and follow the manufacturer's instructions.
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 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 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.
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 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.
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.
Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.
Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.
Orthofix U.S. recalled 61,977 units of the CONSTRUX Mini PTC Spacer System on November 3, 2025. The recall impacts various model numbers due to inconsistent labeling claims. Consumers should stop using the product immediately and follow manufacturer instructions for a refund.
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 3 Food Sensitivity Test Small units distributed nationwide in the United States after a lack of premarket approval was identified. The recall is classified as Class II with a high-level hazard. Consumers should stop using the product immediately and follow the recall instructions from the manufacturer.
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’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 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 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'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 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 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.