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.
SeaSpine Orthopedics Corporation is recalling SeaSpine Polyaxial Head (REF Number: 41-3010) because the component may pop off the screw during surgery.
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.
Brooklyn Roasting Works LLC is recalling Brooklyn Roasting Company Pasteurized Cold Brew Concentrate because ambient storage may lead to Clostridium botulinum toxin formation.
The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.
PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.
Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.
GELLERT GLOBAL GROUP is recalling Fusia Asian Inspirations Kimchi & Tofu Kimbap because it contains undeclared fish.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.
Ford Motor Company is recalling certain 2021-2023 F-150 and 2023-2026 F-250 SD vehicles because a software error can obstruct the rearview camera image.
Ford is recalling 2023-2025 Mustang Mach E vehicles because rear side quarter window glass trim may detach, creating a road hazard and increasing crash risk.
Grand Design is recalling 2026 Imagine travel trailers because improperly secured outlet cover screws may contact wiring, increasing the risk of a fire.
Grand Design is recalling 2026-2027 Lineage motorhomes because incorrect rear tire pressure labels may lead to over-inflation and increased crash risk.
Grand Design is recalling 2027 Imagine recreational trailers because an inverter circuit may overheat, increasing the risk of a fire.
Jayco is recalling certain 2024-2026 Entegra motorhomes because exterior brake lights may stay on when brakes are not applied, increasing crash risk.
PACCAR is recalling 2027 Peterbilt and Kenworth trucks because oil contamination in the power distribution center may cause loss of drive power, ABS, or lighting.
Foretravel is recalling 2025-2027 Realm and Realm Presidential motorcoaches because exterior brake lights may stay on, increasing crash risk.
Frontrunner is recalling 2025 transit buses because wheelchair retractors may fail to lock, increasing injury risk. Owners will be notified to have parts replaced.
Aojieni Silicone is recalling about 5,918 Sili Factory Pull String Teething Toys because the silicone strings violate toy safety standards and can lodge in a child's throat, posing a serious choking risk.