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.
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.
Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.
Hix Sauces Buffalo Wing Sauce is being recalled because the product label declares butter but does not list milk as an ingredient, creating an allergen risk for consumers with milk allergies.
Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.
Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.
Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.
Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.
The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.
Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.
Natural Foods Inc is recalling BulkFoods.com brand Basic Vegetable Starter products due to potential Salmonella contamination in the celery ingredient. The recall affects 1lb and 5lb bags and 20lb boxes distributed across 23 US states.
Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.
WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.
Medtronic is recalling Custom Pack HY10D90R2 sterile perfusion system tubing packs manufactured with insufficient or incomplete welds, which could compromise device integrity during use.
Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.
Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.
Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.