Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.
The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
Publix Super Markets is recalling Egg Custard Pie due to undeclared coconut, a tree nut allergen. Consumers with coconut allergies should not consume the product.
Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.
Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.
Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.
Legacy Pharmaceutical Packaging LLC is recalling 161,664 bottles of Sertraline Hydrochloride 100 mg tablets distributed in California and Arkansas due to inadequate line clearance during manufacturing that may result in product comingling.
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.
Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.
Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.
Valley Meats LLC is recalling approximately 6,768 pounds of raw ground beef products produced on December 22, 2023, due to possible E. coli O157:H7 contamination.
Villa International is recalling certain pedestals and seat anchorages because improper welding may cause the seat assembly to loosen or detach, increasing injury risk.
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.