Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 1,651–1,700 of 7,959

Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Accriva Diagnostics, Inc.
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Diasol, Inc
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Class II
Medical Device Recall · November 5, 2025
Cepheid
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Class II
Medical Device Recall · November 4, 2025
Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II
Medical Device Recall · November 4, 2025
Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Environmental Pollutants Profile Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Syphilis Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Pet Allergy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Urinary Tract Infection Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Pollen Allergy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Sperm Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Drug Test Small (4 substances)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Sperm Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Diabetes Test (ketones & glucose)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
NAD Profile Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class I
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Blood Type Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
3 in 1 STI Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Alcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Biological Age & Longevity Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Estrogen & Progesterone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
PSA Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Neurotransmitters Basic
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Hair Mineral Analysis
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Female Fertility Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Iodine Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Candida Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Akkermansia Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
HPV Antigen Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Intolerance Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Men s Hormone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Mycotoxin Panel Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gonorrhea test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Peptic Ulcer Test (H, pylori)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
H pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
D-Dimer Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Fructose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Kidney Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
IBS Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
SIBO Test
Distribution without premarket approval/clearance.
Class II