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.
GE Healthcare is recalling Omnipaque (iohexol) Injection, 300 mg/mL, over the presence of particulate matter. The action covers 866,570 vials distributed nationwide.
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 custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.
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.
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.
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.
Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 12.5 g per 250 mL in freeflex bags, citing lack of assurance of sterility.
Preferred Pharmaceuticals is recalling six lots of Artificial Tears Lubricant Eye Drops manufactured by Geri-Care, citing lack of assurance of sterility. 720 bottles are affected.
Molded Products is recalling the MPC-130 See Luer Cap Set following a confirmed complaint that the threaded sleeve was not engaged and became detached. 26,900 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.
Zarlengo Italian Ice is recalling Zarlengo's Double Dark Chocolate Gelato in 1-gallon buckets because soy lecithin is listed in the ingredients but soy is not disclosed in the allergen statement, posing a risk to consumers with soy allergies.
Fresenius Kabi is recalling three batches of 5% Dextrose Injection, USP, 5 g per 100 mL in freeflex bags, citing lack of assurance of sterility.
Tornier HRS Max tuberosity bodies and a trial component were incorrectly labeled as HRS Max products; they are compatible only with the Tornier HRS system. 233 units are affected.
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.
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.
Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.
Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs because the cuff can detach from the bladder at the welding connection, leaving it unable to maintain pressure.
Fagron Sterile Services is recalling Vancomycin HCl 1 gram in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Zarlengo's Chocolate Gelato is being recalled because soy lecithin appears in the ingredients statement but soy is not declared in the contains statement.
Cook Medical is recalling Approach CTO-12 Micro Wire Guides 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.
Fagron is recalling norepinephrine bitartrate 32 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation distributed by BD, citing lack of assurance of sterility.