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.
Patoolio Direct electric pressure washers are recalled because they lack an integral ground-fault circuit interrupter, posing shock and electrocution hazards. 2,066 units are affected.
Altec is recalling 2025-2026 AM Series Aerial Devices because the emergency stop switch may fail to cut power, increasing injury risk.
Fengrong Tool electric pressure washers are recalled because they lack an integral ground-fault circuit interrupter, posing shock and electrocution hazards. About 500 units are affected.
Certain Generac portable generators are recalled because fuel can leak from the carburetor when the generator is first filled with gasoline. 114 fuel leak reports have been received; no injuries.
Sanlebi Pet Vet Playsets are recalled because the button cell batteries in the nail grinder and otoscope can be easily accessed by children. About 4,650 units are affected.
Le Hao Tool electric pressure washers are recalled because they lack an integral ground-fault circuit interrupter, posing shock and electrocution hazards. 3,100 units are affected.
LED Finger Beam Lights are recalled because they contain button cell batteries that can be easily accessed by children, violating the mandatory safety standard for toys.
Teva is recalling three lots of Isotretinoin Capsules, USP, 30 mg because the product was found to be superpotent and subpotent. 21,984 packages are affected.
Zarlengo's Chocolate Gelato is being recalled because soy lecithin appears in the ingredients statement but soy is not declared in the contains statement.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
MicroScan Neg Multidrug Resistant MIC 1 panels are being recalled because of a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. Three boxes are affected.
Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
Xtant Medical is recalling Xpress Pedicle Screw System dual lead screws from one lot that were mislabeled with a part number identifying them as shorter than they physically are.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by Fresenius Medical Care RTG, citing lack of assurance of sterility.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 2.5 g per 50 mL supplied in 100 mL freeflex bags, citing lack of assurance of sterility.
F&S Fresh Foods is recalling ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich because the sandwich contains visible sesame but the label does not declare sesame, posing a risk to consumers with sesame allergies.
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation, citing lack of assurance of sterility. Two batches are affected.
A circuit board issue in Multi-parameter Command Module model 91496 can start cardiac output measurement early in Auto mode, producing errors and inaccurate readings. 1,790 units are affected.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 500 mL freeflex bags under its own label, citing lack of assurance of sterility.
Fresenius Kabi is recalling 0.45% Sodium Chloride Injection, USP in 250 mL freeflex bags, citing lack of assurance of sterility.
Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.