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.
OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.
BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.
Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.
Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.
Mazda is recalling 2025 CX-50 and certain 2024 models due to a forward sensing camera malfunction that may prevent automatic emergency braking and lane-keep assist systems from functioning, increasing crash risk.
Nova Bus is recalling certain 2023-2024 LFS buses due to defective instrument panel firmware that may fail to display the speedometer or warning lights, and may cause loss of drive power, increasing crash risk.
Alltrade Tools LLC is recalling Kilimanjaro E-bike racks sold at Costco because connection points may crack, causing the rack to fail and the bicycle to detach.
Altec is recalling 623 units of 2024 spray trucks and aerial devices because fuel or brake lines may not be properly secured, posing risks of brake failure or fire.
Fisher-Price is recalling a plastic dumbbell toy sold in the Baby Biceps Gift Set because the gray caps on the ends can come off, posing a choking hazard to infants. The firm has received seven reports of the ends coming off but no injuries have been reported.
Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.
Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are distributed nationwide and internationally.
Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.
Lunds Mitchell Rd LLC is recalling L&B Beautiful Morning Glory Muffins (Product #49025, Lot 301355) distributed in Minnesota due to potential metal contamination in the product.
Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.
Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.
Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.
Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.
BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.