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 Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.
General Mills is recalling Pillsbury Bread Rolls Hard Roll Dough due to potential glass contamination. Affected products were distributed across multiple states.
Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.
Medtronic is recalling certain DLP One-Piece Pediatric Arterial Cannulas (Product Number 77010) due to complaints of loose foreign material containing trace levels of blood found in the devices.
Orthofix U.S. LLC is recalling 19 units of Orthofix MINIRAIL orthopedic external fixation devices distributed across the US due to incorrect model labeling that could lead to surgical use of the wrong device.
General Mills is recalling Pillsbury Bread Rolls, Kaiser Roll Dough due to potential foreign glass material in the product. Affected consumers should not consume the product and should contact the company or retailer for a refund.
Chocolate Bar Holdings LLC is recalling Winfield's CWB Chocolate Bars in multiple shapes and sizes due to undeclared milk allergen. Consumers with milk allergies should not consume these products.
Fayus Inc. is voluntarily recalling OLA-OLA Pounded Groundnuts because the product contains undeclared peanuts, a major allergen, which poses a risk to consumers with peanut allergies.
Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.
GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.
GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.
Bell Pharmaceuticals is recalling Audiologist's Choice Carbamide Peroxide earwax removal product due to subpotency: the active ingredient concentration is approximately 0.6% instead of the expected 6–7%, and the product has low pH.
Bell Pharmaceuticals recalls Foster & Thrive Carbamide Peroxide 6.5% due to subpotent drug substance with low pH and significantly reduced assay levels. Approximately 31,094 units distributed nationwide are affected.
Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.
Nutricia North America is recalling Liquid Hope Organic Whole Foods Meal Replacement Peptide Formula Berry Medley because the product contains less vitamin A than labeled. A testing laboratory used an incorrect method that overstated the vitamin A concentration.
Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.
Bell Pharmaceuticals is recalling TopCare Earwax Removal Kit (Carbamide Peroxide 6.5%) because the drug is subpotent with significantly reduced active ingredient (~0.6% vs. expected 6–7%) and low pH. The affected product was distributed nationwide.
Papablic Inc is recalling certain Papablic18B replacement brush head packs because the brush heads may break during use.
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.
CVS Health Earwax Removal Drops are being recalled because the product contains significantly reduced active ingredient (approximately 0.6% instead of the expected 6–7%) and has low pH. The recalled product may not work as intended.
Family Wellness Carbamide Peroxide 6.5% earwax removal kits are being recalled because they are subpotent with low pH and significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%). Consumers should stop using affected lots and consult their pharmacist.
Padagis US LLC is recalling Nystatin Cream USP (100,000 USP units) because long-term stability testing found assay results below specification, meaning the product may contain less active ingredient than labeled.
CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.