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.
Diva Fam is recalling Sea Moss Gel Superfood in the Orange variety over potential Clostridium botulinum contamination.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the Menopause Test Cassette (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Diva Fam is recalling Sea Moss Gel Superfood in the Soursop variety over potential Clostridium botulinum contamination.
Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Diva Fam is recalling Sea Moss Gel Superfood in the Pineapple variety over potential Clostridium botulinum contamination.
Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Granules Pharmaceuticals is recalling 71,424 bottles of Trazodone Hydrochloride, USP 50 mg, over the presence of foreign tablets or capsules.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Triumph is recalling certain 2022-2024 Bonneville, Street Twin, Street Scrambler, Speed Twin 900 and Scrambler 900 motorcycles because the wiring between the alternator and main harness connector may short circuit.
Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.
CS Beef Packers is recalling approximately 22,912 pounds of raw ground beef products that may be contaminated with E. coli O145. The products were distributed to foodservice locations in California, Idaho, and Oregon.
Changchun Wancheng Bio-Electron is recalling 3,000 units of Vivoo Vaginal pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Imu-Tek Animal Health is recalling 113 bottles of Imu-Tek Immuno-5 Colostrum Powder, 7 oz, over an undeclared milk allergen.
Rich Products is recalling 2,792 cases of Gluten Free 14" Seasoned Vegan Pizza Crust because the product contains undeclared milk and egg.
Diva Fam is recalling Sea Moss Gel Superfood in the Strawberry variety over potential Clostridium botulinum contamination.
Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.