FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1721–1740 of 39,430 recalls

Class IIOngoing

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Accriva Diagnostics, Inc.

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.

November 5, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

Safety and efficacy of dialysis acid concentrate cannot be assured

November 5, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

Safety and efficacy of dialysis acid concentrate cannot be assured

November 5, 2025 · DeviceView details →

FDA Device Recalls

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Food Intolerance Test Small

Vitamin D-Test

Candida Test

Organic Acids Profile Test Large

Allergy Test IgE

Allergy test Small

GI Microbiome Profile XL

Illegally Marketed

HPV Antigen Test

Sperm Test

Mycoplasma test, IgG and IgM

Parasite Test

Adrenal Test

Neurotransmitters Plus

Pollen Allergy Test