Class IIOngoingZ-0733-2026
GET TESTED INTERNATIONAL AB recalls Illegally Marketed
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 241–252 of 2,908 recalls
Class IIOngoingZ-0732-2026
GET TESTED INTERNATIONAL AB recalls Diabetes HbA1c Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0731-2026
GET TESTED INTERNATIONAL AB recalls D-Dimer Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0730-2026
GET TESTED INTERNATIONAL AB recalls Chlamydia Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0729-2026
GET TESTED INTERNATIONAL AB recalls Candida Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0728-2026
GET TESTED INTERNATIONAL AB recalls Blood Type Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0727-2026
GET TESTED INTERNATIONAL AB recalls Alcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0726-2026
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Medtronic, Inc.MNDec 10, 2025
Class IIOngoingZ-0725-2026
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient…
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Enterix, Inc.NJDec 10, 2025
Class IOngoingZ-0586-2026
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IIOngoingZ-0724-2026
Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
- Direct Specimen Resistance Marker Mycobacterium Tuberculosis Complex Nucleic Acid-Based System
- Under Investigation by firm
CepheidCADec 3, 2025
Class IIOngoingZ-0723-2026
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS - InteleConnect / TechPortal
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studi…
INTELERAD MEDICAL SYST…Dec 3, 2025