Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.
The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.
Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.
Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.
Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.
Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.
Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.
Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.
Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.
Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.
Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.
Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT diagnostic kits due to misleading label statements that could affect proper use and test interpretation.
Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.
Preat Corp is recalling Neodent GM X 6mm titanium base components due to a dimensional defect causing vertical movement. This instability may lead to abutment fracture and potential ingestion of dental materials by patients.
Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.
The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.
Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.
GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.
Entopsis, Inc. is recalling PCRopsis BCSNano nucleic acid extraction kits due to misleading statements on the product label. The affected lot (Lot 3, expiring 11/2023) was distributed nationwide and internationally.
Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.