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.
Aurolife Pharma has recalled Glycopyrrolate Tablets (1 mg) nationwide due to failed impurity and degradation specifications. Affected lot 01421038A1 expires May 2023.
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.
Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.
Fire Distributors Plus LLC is recalling Earth Kratom Trainwreck capsules because they contain kratom, an unapproved food additive. Consumers should not use these products.
Cascade International Foods is recalling approximately 35,686 pounds of Fresh Organic Freezer Strawberries from Mexico distributed in California and Oregon due to potential Hepatitis A contamination.
Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.
NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.
SOFT HANDS Alcohol Antiseptic 80% hand sanitizer is recalled nationwide due to FDA detection of methanol contamination. Approximately 7,303 gallons were distributed with manufacture dates from March to August 2020.
Jarman's Midwest Cleaning Systems recalled 2,365 gallons of 80% alcohol antiseptic hand sanitizer nationwide due to FDA-detected methanol contamination. Consumers should stop using affected products immediately.
Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.
Mechanical locking devices for prosthetic sockets may develop accelerated wear that causes the attachment pin to disengage, potentially leading to loss of prosthetic suspension and falls.
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.
Tillamook Chocolate Peanut Butter ice cream cartons were mislabeled and contain Waffle Cone Swirl ice cream with undeclared wheat and soy allergens. The affected cartons were distributed in Idaho and Washington.
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.
Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.
Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.
LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.