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.
Family Dollar is recalling GS Denture Cleanser tablets (green and overnight formulas) due to improper storage in non-temperature-controlled areas. Products sold May 1 - June 10, 2022 may be affected.
Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.
KY Jelly Lubricant 2 FL OZ (SKU 901443) distributed at Family Dollar stores was not stored in temperature-controlled areas. Consumers should discontinue use of product purchased between May–June 2022.
Family Dollar is recalling DENTEMP temporary dental filling products (SKU 902139) that were stored outside temperature-controlled conditions. The product was sold at Family Dollar stores nationwide between May and June 2022.
Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.
FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
Big Olaf frozen ice cream products in all flavors and sizes distributed in Florida and Ohio are being recalled due to potential Listeria monocytogenes contamination. Listeria can cause serious illness.
The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.
Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.
McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.
Natierra Nature & Earth Organic Blueberries are recalled due to elevated lead levels detected by Maryland Department of Health testing. The recall affects 22,014 units distributed nationwide.
Clear American brand Strawberry Punch Snow Cone sparkling water is being recalled because it may contain undeclared coconut. The product is distributed across 14 states and should not be consumed by people with coconut allergies.
Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.
HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.
Strides Pharma is recalling Prednisone 20 mg tablets due to contamination with 2.5 mg tablets. No illnesses have been reported, but patients may receive incorrect doses.
Mckesson Medical-Surgical has recalled Eye-stream eye wash solution nationwide due to storage conditions outside drug label specifications.
Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.
SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.
GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.