2,229 recalls tagged with “stop use 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 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions immediately.
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 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 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.
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 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
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 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.
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.
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 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.
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 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.
GET TESTED INTERNATIONAL AB recalled 18 units of Neurotransmitters Plus on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients should cease use immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 5 chlamydia test devices distributed nationwide in the United States after regulators found distribution without FDA premarket approval or clearance. The devices lack required premarket authorization. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB's Lyme Test devices were distributed nationwide in the United States to healthcare providers. Regulators found the devices were distributed without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow recall instructions.