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.
Mondelez Global LLC recalls belVita Breakfast Sandwich (Dark Chocolate Creme variety) due to undeclared peanut allergen from cross contamination. The product was distributed to all 50 states.
Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.
Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Medline Industries is recalling 1,218 procedural kits because the sterile ultrasound gel component may not meet sterility specifications, potentially posing an infection risk in invasive procedures.
Central Admixture Pharmacy Services is recalling 516 Neonatal TPN Starter Bags due to insufficient validation of decontamination processes. The recall affects bags distributed nationwide.
Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Medline is recalling approximately 9,017 breast biopsy and ultrasound surgical kits due to potential sterility failures in the included ultrasound gel component. No illnesses have been reported.
DOUBLEDAY'S Premium Dough packages may contain undeclared soy flour, posing risk to consumers with soy allergies. The recall affects 24,575 cases distributed across nine states.
Central Admixture Pharmacy Services is recalling 3,648 bags of vancomycin IV bags due to lack of assurance of sterility caused by insufficient validation data for decontamination cycles.
Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.
Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.
Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.
Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.
Medline is recalling 83,541 procedural kits because the included ultrasound gel component may not meet required sterility specifications.
Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.
Cassanos Inc is recalling Prima Guida Traditional Homestyle Sheeted Pizza Dough in multiple sizes due to undeclared soy flour. Consumers with soy allergies should not consume this product.
Central Admixture Pharmacy Services recalls 150 fentanyl injection syringes nationwide because sterilization procedures were not properly validated.
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.
Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.
Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.
Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.