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.
A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.
SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.
Little Moon Essentials is voluntarily recalling Ass Kisser due to CGMP deviations identified in the manufacturing process. The recall affects 165 metal tins distributed nationwide in the USA and Canada.
Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, Canada.
Little Moon Essentials has voluntarily recalled Vital Vapor Balm (camphor 0.6%, menthol 5.2%) due to Current Good Manufacturing Practice deviations. The Class II recall affects 1,041 units distributed nationwide in the United States and Canada.
Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.
Grato Holdings is recalling BioActive Nutritional MINAPLEX botanical herbal supplement due to potential yeast and mold contamination. The recall involves 261 bottles (lot J28761) distributed nationwide in the US and Canada.
Little Moon Essentials is recalling Magical Muscle Oil due to manufacturing practice deviations. The recall affects 1,654 glass jars distributed nationwide in the USA and Canada.
The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.
Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.
Little Moon Essentials Crampy Belly Rub, a camphor-based topical product, is being recalled nationwide and in Canada due to manufacturing deviations. The firm-initiated recall affects 788 glass jars.
Little Moon Essentials Clear Breeze Plus Hand Sanitizer is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the USA and Canada.
Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.
Dr. Reddy's Laboratories is recalling 13,752 bottles of Eszopiclone 1mg tablets due to failed impurity and degradation specifications. Lot C2302598 was distributed in Ohio and Mississippi.
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
AMB FOODS INC is recalling Pop a Nosh Mixed Munch snacks due to undeclared wheat allergen. Approximately 2,100 units distributed in New York contain wheat, which is not labeled on the product.
Queso Chonero Special White Cheese has been recalled due to Listeria monocytogenes contamination. The product was distributed in Illinois.
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.