Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.
Cheer Pack is recalling certain flexible food pouches because they may release thin plastic strips into food products.
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.
PT Organics Limited is recalling certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree pouches due to the potential presence of thin, soft plastic strands.
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Central Admixture Pharmacy Services is recalling two patient-specific pediatric TPN bags due to incorrect product formulation. The recall affects lots 20-1535990-0-1 and 20-1535892-0-1 with an expiration date of July 16, 2026, distributed in Georgia only.
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
Nelson & Isa Lacteos LLC is recalling 480 1-lb packages of Requeson soft ricotta sold in NY because the product may be contaminated with Listeria monocytogenes.
ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.
Medical Action Industries is recalling cardiovascular procedure kits containing manifolds that may have particulate in the fluid path, which could enter blood circulation and lodge in blood vessels. FDA Class I.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.
Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.
Windstone Medical Packaging is recalling 465 AMS medical convenience kits in connection with a Medicom recall of Ritmed Neurological Sponges due to potential endotoxin level variability.
Stryker is recalling Hoffmann II Carbon Connecting Rods (catalog 50796040) because they may crack after cleaning and sterilization.
Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, and organ dysfunction.
Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.
Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Permobil is recalling M3 Corpus Power Wheelchairs with firmware version 1.26.2 because the firmware lacks a speed restriction when the seat lift exceeds 50 mm, which may cause falls or tip-overs.
Mellish Island Corp. is recalling 1,600 bottles of Super Skin dietary supplement because the label does not declare that its marine collagen comes from fish, a potential allergen.
Stryker is recalling Hoffmann II Carbon Connecting Rods (catalog 50796120) because the rods may crack after cleaning and sterilization. The recall covers 5,439 units distributed worldwide.
Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.