December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Mycoplasma test, IgG and IgM
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls MPOX Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Menopause (FSH) 2 Tests
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Lyme Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Iron Deficiency Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls HPV Antigen Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Herpes (HSV-1 & HSV-2) Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls H pylori (Peptic ulcer) Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Gonorrhea test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Female Fertility Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Fecal Occult Blood Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Drug Test Small (4 substances)
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Illegally Marketed
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Diabetes HbA1c Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls D-Dimer Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Chlamydia Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Candida Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Blood Type Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Alcohol (ALC) Test Saliva
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product
Hazard: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
December 10, 2025Medical DevicesFDA
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001
Hazard: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
December 10, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).
Hazard: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
December 3, 2025Medical DevicesFDA
Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Hazard: Product testing did not meet expected stability criteria.
December 3, 2025Medical DevicesFDA
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS - InteleConnect / TechPortal
Hazard: 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 studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
December 3, 2025Medical DevicesFDA
DJO, LLC recalls Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Hazard: 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 capable of causing a second degree burn.
December 3, 2025Medical DevicesFDA
Mindray DS USA, Inc. dba Mindray North America recalls Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Sa
Hazard: Potential for anesthesia leakage.
December 3, 2025Medical DevicesFDA
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (S
Hazard: Potential for anesthesia leakage.
December 3, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Hazard: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
December 3, 2025Medical DevicesFDA
B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
Hazard: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).