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.
Neuroquell and Neuroquell Plus, 0.22 fl oz, distributed by Claire Ellen Products, are recalled for cGMP violations. 72 containers sold via the internet are affected.
Iodo Blanco Iodides First Aid Antiseptic, iodine 2%, lot 230619, is recalled because of a defective container: broken or leaking bottles. 3,900 bottles distributed in Florida are affected.
Artis Pheno image-intensified fluoroscopic X-ray systems are recalled because of limited system movements after startup. 20 units are affected.
ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.
PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.
The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.
Sulfamethoxazole and Trimethoprim double strength tablets distributed by Cardinal Health are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.
CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.
ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.
Hershey's Ice Cream Green Mint Chip bulk 3-gallon cans, lot 25223M, are recalled after routine testing found elevated coliform counts. 81 cans are affected.
NOxBOXi Nitric Oxide Delivery Systems are recalled for replacement of the internal sample pump because of high failure rates. 1,667 units are affected.
Organic BABY bedtime drops, a liquid dietary supplement for ages 4 months and up, are recalled in lots 25084 and 25086 because of the potential for spoilage due to yeast contamination. 85,248 bottles are affected.
DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.
Taylor Farms Honey Balsamic Salad Kits, 8.3 oz, are recalled for undeclared sesame and soy. The FDA classified the action as Class I. 8,284 cases are affected.
The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
Micro Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
IDM-MULTI-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.
Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.