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 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.
Philips is recalling 344 Ingenia Ambition S MRI systems because the patient support table floor plate may be incorrectly installed.
Philips is recalling Ingenia 3.0T MRI systems due to incorrect patient support table floor plate installation. Affected healthcare facilities should verify installation status and contact Philips for corrective action.
Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.
Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.
Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.
Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.
Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.
Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.
Weis Markets, Inc. is recalling Angel Creme Filled Chocolate Iced Donuts due to the presence of metal fragments. Consumers should not eat the affected product.
Philips is recalling 166 units of the MR 5300 Magnetic Resonance System worldwide because the patient support table floor plate may be incorrectly installed on affected units.
Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.
Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
Philips is recalling 12 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.
Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.
Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.
Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.
Weis Markets is recalling Peanut Butter Filled Iced Donuts due to foreign material (metal) found in the product. Affected donuts were distributed at a retail store in Pennsylvania with sell-by dates between March 15–18, 2024.
Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.