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.
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.
Shakespeare's Pizza is recalling 18,712 frozen pizzas due to undeclared wheat. The product was sold in retail stores in Missouri and Kansas and through online sales; consumers with wheat allergies should not consume it.
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.
Shakespeare's Pizza Vegetarian Pizza is being recalled because it contains undeclared wheat, a common allergen. Affected products were distributed to retail stores in Missouri and Kansas and through online direct sales.
Klein Tools and Blackfire portable rechargeable power stations are being recalled because their internal inverter boards can overheat, creating fire and burn hazards. Consumers should stop using the units and return them to their original point of purchase.
Pella Corporation is recalling approximately 12,000 Architect Series Casement Windows because the window sash can detach from the frame and fall, creating an injury risk. The company has received one report of detachment but no injuries have been reported.
FeraDyne Outdoors is recalling about 50,000 Rhino Tree Stands because the safety harness stitching can rip, creating a fall hazard. No injuries have been reported.
Litti City Premier Doctor and Teacher Purse playsets, Litti Pritti Stylist Handbag set, and Prextex Slime Eggs are recalled for containing phthalates and lead exceeding federal safety standards. No injuries have been reported.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
Gaws Gourmet Foods is recalling Gaw's Deluxe Italian sub sandwiches because sesame was not declared on the label. The recalled products were distributed in Michigan.
Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Ben E Keith Foods is recalling 1,721 cases of frozen tilapia fillets and tuna loin products due to temperature abuse during transport. Products were distributed to food service operations.
Ben E Keith Foods is recalling frozen and refrigerated shrimp and other food products that were temperature abused while stored in a food trailer. The products were distributed to food service establishments.
Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.
Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend because the product contains kratom, an unapproved food additive, and has a pH level exceeding the required maximum for acidified products.
Gaws Gourmet Foods is recalling Gaw's Salami & Cheese Bagel 6oz due to undeclared sesame allergen. Affected products have use-by dates from November 28 through December 15, 2023.
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.