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.
VANTIVE US Healthcare is recalling 264,040 PRISMAFLEX ST150 dialyzers nationwide due to potential dislodgement of the deaeration chamber from the control unit during use.
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Fujirebio Diagnostics is recalling the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test because it may produce falsely elevated positive or indeterminate results, causing patients to be incorrectly classified as having Alzheimer's disease or requiring unnecessary further testing.
Fujirebio Diagnostics is recalling Lumipulse β-Amyloid Plasma Controls due to falsely elevated test results that may cause incorrect classification of Alzheimer's disease status. The quality control product may provide false positive or unnecessary indeterminate results.
Vortex Surgical is recalling Oertli laser probes due to voids in Tyvek pouches that could compromise the sterile barrier and lead to infection risk.
Vortex Surgical is recalling its 25GA Internal Delivery Device due to voids in pouch seals that may compromise sterility, allowing potential bacterial contamination that could lead to infection.
FDA is recalling Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges due to inaccurate test results that may falsely classify patients as having Alzheimer's disease pathology or requiring unnecessary clinical testing.
Siemens is recalling software applications used in NAEOTOM Alpha CT systems because they lack FDA 510(k) clearance. The recall affects 88 units.
Vortex Surgical is recalling Tecfen Retractable Membrane Polishers due to potential voids in sterile pouches that could compromise the barrier and allow bioburden contamination. Approximately 8,651 units were distributed in the US.
Three brands of urinalysis and ketone test strips have been recalled because they were distributed without required FDA approval and may produce inaccurate diagnostic results. False or incorrect readings could lead to inappropriate medical decisions.
Olympus recalls 999 units of Disposable Triple Lumen Sphincterotomes due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during use.
Vortex Surgical Inc. is recalling 25GA Subretinal Injection Cannulas due to voids in the sterile Tyvek pouches that could allow bioburden contamination and potentially lead to infection.
Vivoo pH Test strips were distributed before obtaining required FDA clearance. The devices may produce false or inaccurate results when used by consumers, potentially leading to inappropriate medical treatment.
Vortex Surgical is recalling disposable forceps and cannulas due to voids in Tyvek pouch seals that could compromise sterile barriers and allow bioburden contamination, potentially leading to infection.
A software error in the CellMek SPS Sample Preparation System causes samples to be dispensed incorrectly, resulting in sample loss of 60-100 microliters. This could lead to incorrect laboratory results and patient management decisions.
Lumipulse G plasma calibrators may produce inaccurate test results, causing false positive or indeterminate classifications for Alzheimer's disease. 128 units are affected nationwide.
Olympus is recalling its Single Use Sphincterotome V devices that may not have undergone proper thermoforming, which could cause them to deform and lose performance.
Vortex Surgical Inc. is recalling Rumex Disposable Diamond Dusted ILM Elevators due to voids in sterilization pouch seals. The compromised barrier could allow contamination and lead to infection during surgical procedures.
Olympus Corporation is recalling Disposable Triple Lumen Sphincterotomes (Model KD-401Q-0725) because some units did not undergo proper thermoforming during manufacturing and could deform and lose performance.
Olympus is recalling 413 units of Single Use 3-Lumen Sphincterotomes (Model KD-VC412Q-0215) distributed in the United States because some devices may not have undergone proper thermoforming and could deform and lose performance.
Beacon Promotions Inc is recalling repackaged M&Ms Peanut candies (1.3 oz) due to undeclared milk, soy, and peanut allergens. The affected lot (M1823200) was distributed across 19 states.
BarbaCuban 90 Miles to Mojo Marinade distributed in Florida is recalled due to undeclared quinine. Prima Foods International voluntarily recalled 12,214 bottles of the product.
Diva Fam Inc is recalling Sea Moss Gel Superfood (strawberry, 16 FL OZ) due to potential Clostridium botulinum contamination. The product is distributed nationwide through retail and online sales.
Venzu Traders LLC is recalling cinnamon powder (3.5 oz packs) due to potential contamination with the heavy metal lead. The product was distributed in California, Nevada, and Washington.
Diva Fam Inc is recalling Sea Moss Gel Superfood (16 FL OZ) due to potential Clostridium botulinum contamination. The affected products were distributed nationwide through retail and online sales.