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.
Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.
Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.
Cardinal Health Inc. recalls one lot of TRULICITY (dulaglutide) injection due to temperature abuse. The product was exposed to temperatures outside the manufacturer's labeled storage conditions.
Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.
Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.
Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.
Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
R & S Roberts Enterprises is recalling Milk & Dark Chocolate Himalayan Salted Caramels distributed in Washington because product labels do not disclose soy lecithin, a major allergen.
HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.
R & S Roberts Enterprises recalls Milk & Dark Chocolate Caramel Macchiato candies distributed in Washington due to undeclared soy lecithin. Consumers with soy allergies should not consume the product.
R & S Roberts Enterprises is recalling Milk & Dark Chocolate Healthy Bites due to undeclared soy lecithin. Products were manufactured on 03/11/2022 and distributed in Washington.
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.
Turkey Hill is recalling 48-ounce packages of Chocolate Marshmallow Premium Ice Cream sold in Pennsylvania due to undeclared peanuts. Consumers with peanut allergies should not consume this product.
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.