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.
Power Snacks Honey Roasted Sunflower Kernels are being recalled nationwide due to potential undeclared soy and wheat allergens from mislabeling. Approximately 88,084 units are affected.
Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.
The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.
TRP Natural Eyes Sterile Eye Ointment is recalled due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.
TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.
Mount Franklin Foods is recalling three varieties of honey roasted cashews nationwide due to undeclared soy and wheat allergens caused by mislabeling.
AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.
Fox Confections is recalling 138 packages of F-Bombs Red Velvet Truffles sold in Illinois and Ohio retail locations because they contain undeclared FD&C Yellow #5 and Yellow #6 food colorants, which federal regulations require to be clearly labeled.
Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.
Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.
Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.
Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.
ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.
TRP Natural Eyes Pink Eye Relief sterile eye drops (Lot FP001, expires 07/24) are being recalled due to lack of assurance of sterility. Consumers with this product should stop using it and consult their healthcare provider.
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
TRP Natural Eyes sterile eye ointment (NDC 17312-165-13, Lot 180001, EXP 01/25) is being recalled due to lack of assured sterility. The product was distributed to accounts in Rhode Island and Colorado.
TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.
TRP Natural Eyes Floaters Relief sterile eye drops are being recalled because the manufacturer cannot assure the product meets sterility standards. It was distributed to two direct accounts in Rhode Island and Colorado.
TRP Natural Eyes Red Eye Relief sterile eye drops have been recalled due to lack of assurance of sterility. The recall affects 8,868 units distributed to accounts in Rhode Island and Colorado.
O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.
Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.
TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.
Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.