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.
Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.
HeartSine Technologies is recalling 31,834 public access defibrillators distributed without the required Maintenance Supplement, which describes an extra check every 3 months.
Karl Storz Endoscopy is recalling six HOPKINS Telescope eyepieces because of incorrect inside packaging labels. The units were distributed in Arizona, California, and Missouri.
AVID Medical is recalling Halyard IV Start Kits because they contain applicators potentially contaminated with Aspergillus penicillioides.
Evergreen Fresh Sprouts LLC is recalling broccoli sprouts in Washington due to a potential Salmonella contamination risk.
GIAS FOOD INC. is recalling Bettergoods Lemon Alfredo Fettuccine due to Listeria monocytogenes contamination. Consumers should stop eating the product and return it to Walmart.
Sterling Pharmaceutical Services LLC is recalling specific lots of Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant due to a lack of assurance of sterility.
CooperSurgical is recalling specific lots of INCA Infant Nasal CPAP tubing because a loose connection may cause loss of pressure and reduced oxygenation.
Sterling Pharmaceutical Services LLC is recalling Walgreens Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 199,600 packs distributed nationwide.
Whole Foods Market is recalling Cabricharme cheese sold in several states due to an undeclared egg allergen. Consumers should check their refrigerators and discard or return the product.
Sterling Pharmaceutical Services is recalling Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, due to a lack of assurance of sterility.
Sterling Pharmaceutical Services LLC is recalling specific lots of Lubricating Tears because the company cannot guarantee the product is sterile.
Sterling Pharmaceutical Services LLC is recalling Gentle Eyes Lubricant Eye Drops due to a lack of assurance of sterility.
Sterling Pharmaceutical Services LLC is recalling Major LubriFresh P.M. Nighttime Ointment due to a lack of assurance of sterility. The recall covers 34,368 tubes distributed nationwide.
United Sugar Producers and Refiners is recalling specific batches of United and Good & Gather light brown sugar due to potential wheat kernel contamination.
Sterling Pharmaceutical Services LLC is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution due to a lack of assurance of sterility.
Medline Industries is recalling 128 Major Pack Convenience Kits containing neurological sponges due to potential endotoxin variability that may cause adverse health events.
Olympus is recalling 404 BiCOAG Hemostasis Probes because the ceramic tip may detach due to insufficient adhesive.
Sterling Pharmaceutical Services LLC is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% due to a lack of assurance of sterility.
Insight Pharmaceuticals is recalling 2.3 million bottles of Clear Eyes Redness Relief eye drops due to a lack of assurance of sterility.
Insight Pharmaceuticals is recalling specific lots of Clear Eyes Redness Relief eye drops due to a lack of assurance of sterility.
Sterling Pharmaceutical Services LLC is recalling Walgreens Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product.
Boston Scientific is recalling Imager II Angiographic Catheters because the tip may fracture or detach, potentially causing device fragments to remain in or migrate through the patient's vasculature.
CooperSurgical is recalling 149 boxes of INCA Neonatal Nasal CPAP replacement sets because the flexible tubing may disconnect from the nasal cannula, potentially reducing treatment effectiveness.
Medline is recalling Healthmark Instrument Channel Brush kits due to potential sharp edges that could cause cuts, abrasions, or infection.