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.
First & Last Tavern is recalling 30 cases of Marinara Sauce, tomato and basil, because it may be contaminated with Clostridium botulinum.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.
Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Lil Turtles is recalling 110 cases of Grandma Belle's Tomato Basil Soup over undeclared milk.
Zimmer is recalling 3 Affixus Antegrade Femoral Nails, model 815809280, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors because a connector fault triggers Error 23062 and locks console ergonomics until the motor is replaced.
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815609300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.
Diasol is recalling 2200 gallons of liquid concentrate for bicarbonate dialysis, product 100425-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509380, because an undersized distal shaft diameter could lead to implant fatigue fracture.
First & Last Tavern is recalling 30 cases of Traditional Pasta Sauce, meat flavored, because it may be contaminated with Clostridium botulinum.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.
Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Merck Sharp & Dohme is recalling 845 kits of Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension over the potential presence of metal particulates.
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.