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.
Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Olympus is recalling its Inner Sheath, Long, model WA22017A, used in urological and gynecological applications, after complaints that the ceramic tip of the resection sheath can break.
AvKARE is recalling one lot of Amantadine HCl 100 mg capsules after an out-of-specification finding in dissolution testing.
Gerber is recalling Arrowroot Biscuits in a downstream recall because they contain an arrowroot flour ingredient recalled by the supplier over potential contamination with soft kraft paper and plastic bag pieces.
Vista Gonio Eye Lubricant eye drops are being recalled because they may not be sterile. The product was not manufactured according to proper sterile drug-making standards.
Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.
SB FOOD LLC is recalling Yoyo Gummy Assorted Flavor because the product contains Carmoisine (E122) - Acid Red 14, which is an unallowed color.
Valley Springs Artesian Gold, LLC is recalling various sizes of Valley Springs 100% Natural Bottled Water because the product was bottled under insanitary conditions.
Agiliti Health - Ellis is recalling Adapt Pumps (Model 61600200) because the Microclimate Management function may fail to re-engage after using the Autofirm function.
Valley Springs Artesian Gold, LLC is recalling Valley Springs Steamed Distilled Water because it was bottled under insanitary conditions.
SB FOOD LLC is recalling Yoyo Gummy Tropical Flavor candy because it contains Carmoisine (E122), a color additive not approved for use in this product. The recalled product was distributed to 15 states.
Lubna Quality Products Inc. is recalling 400 cases of mung beans distributed in Texas and Louisiana due to the presence of Thiamethoxam pesticide.
TENGEN USA Trading Corp recalls YO!MAN Lettuce (Spicy Flavor) due to undeclared cyclamates. FDA Class III recall for 26 cases in NY, PA, FL, LA, TX.
Valley Springs Artesian Gold, LLC is recalling 7,840 units of its 1-gallon bottled water due to water being bottled under insanitary conditions. No illnesses have been reported.
Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.
Edermy LLC is recalling the PIE Trolley System, model 2005, because the device lacks 510(k) clearance from the FDA.
Tengen USA Trading Corp is recalling YO!MAN Cucumber (Fresh Hunan Flavor) because the product contains undeclared cyclamates.
Slate Run Pharmaceuticals is recalling Eptifibatide Injection due to a labeling error on the carton, which incorrectly describes the dosing instructions.
Reser's Fine Foods is recalling 298 tubs of tuna salad that were mislabeled with a Molly Kitchen's Chicken Salad lid, leaving fish undeclared.
Art Monkey LLC is recalling 8,500 bottles of Why Not Natural Moringa Capsules because they have the potential to be contaminated with Salmonella.
Lotus Mom Corporation is recalling 9 units of a 4-quart Brass Pital Pot over potential contamination with leachable lead.
Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.
Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.