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.
KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.
Howmedica Osteonics Corp. is recalling 153 units of Triathlon Femoral Distal Augments because a device overhang issue causes them to protrude beyond the mating femoral component.
Voco GmbH is recalling Grandio SO Heavy Flow Caps because the metal cannula may be too loose and detach during use.
Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.
Southeastern Grocers is recalling 18-count Peanut Butter Cookies because the ingredient labels failed to declare peanuts.
Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product cannot be guaranteed.
Quality Electrodynamics LLC is recalling five Siemens MRI extremity coils because unintended ferrous material may be present in the pushbutton assembly.
Whole Flower Farms LLC is recalling Oatmeal Chocolate Chip Cookies due to undeclared soy lecithin. The product was distributed in Oregon.
WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.
Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.
Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.
Valencia Flour Mill, Ltd. is recalling Sopaipilla Mix because it contains undeclared milk. The product was distributed in New Mexico.
Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution because the product's sterility cannot be guaranteed.
Valencia Flour Mill is recalling Sopaipilla and Fry Bread Mix because it contains undeclared milk, a major food allergen.
The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.
Whole Flower Farms LLC is recalling 30 units of Peppermint Brownie due to undeclared soy lecithin. The product was distributed in Oregon.
Quality Electrodynamics LLC is recalling five Siemens 15CH Knee Coils because unintended ferrous material may be present in the pushbutton assembly.
The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed in the US and Canada.
The FDA is recalling 175,392 ExactaMix IV bags due to a potential for leaking. The bags are used for intravenous admixture programs.
Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative results.
The Metrix Company is recalling 1,512 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide in the US.
Quality Electrodynamics LLC is recalling two Siemens knee coils because unintended ferrous material may be present in the pushbutton assembly.
The Metrix Company is recalling 4,284 Secure EVA dual chamber containers due to a potential for leaking. The affected bags are used for intravenous admixtures.
Symrise Inc. is recalling Wow Beef Dry Marinade Seasoning because it contains undeclared milk, a major food allergen.