Class IIOngoingZ-0733-2026
GET TESTED INTERNATIONAL AB recalls Illegally Marketed
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,681–1,692 of 3,893 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 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
Class IIOngoingZ-0722-2026
DJO, LLC recalls Cold Form Wrap: Back
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capa…
DJO, LLCCADec 3, 2025