Recall database
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.
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.
Labeling contains claims that are not consistently present.
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.
Distribution without premarket approval/clearance.
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.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
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 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.
Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Distribution without premarket approval/clearance.
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.