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.
Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.
Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.
OBC GROUP CORP has recalled LA ORIGINAL NUT DIET MAX due to product mislabeling. The product contains Yellow Oleander instead of the labeled Nuez de la India.
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.
Fox Confections is recalling F-Bombs Original Truffles due to undeclared Yellow #5 and Yellow #6 food dyes not listed on the label. Consumers with sensitivities to these dyes may be affected.
Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.
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.
Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.
Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.
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.
Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.
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.
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.
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.
Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.
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.
Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.
DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.
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.
TRP Natural Eyes sterile eye drops are being recalled because the manufacturer cannot assure the product maintains sterility. The recall involves 196,111 units distributed to retailers 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.
Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.
Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.
Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.
TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.