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.
Houston Pecan Company is recalling Black Mission Figs in 5-pound bags distributed in Texas and via internet due to undeclared tree nuts, peanuts, and wheat from allergen cross-contamination.
Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.
Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.
Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.
Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.
Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.
Central Admixture Pharmacy Services is recalling a neonatal IV nutrition bag due to lack of sterility assurance. The recall affects 156 bags of the product distributed nationwide.
Houston Pecan Company is recalling 5-pound bags of pumpkin seeds sold in Texas and online due to potential cross-contamination with undeclared tree nuts, peanuts, and wheat.
Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.
Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.
Houston Pecan Company is recalling 5-pound bags of walnuts that may contain undeclared tree nuts, peanuts, and wheat due to cross-contamination. Affected products were sold in Texas and through internet sales.
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.
Houston Pecan Company is recalling 5-pound bags of pine nuts because they may contain undeclared tree nuts, peanuts, and wheat due to allergen cross-contamination.
Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.
Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through April 2023.
Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.