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
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Olympus is recalling approximately 11,779 Single Use 3-Lumen Sphincterotome V surgical instruments distributed in the US. Some devices may not have undergone proper thermoforming, which could cause them to deform and lose performance during use.
Vivoo Protein Test strips were distributed without FDA clearance. The unapproved devices may produce false or inaccurate diagnostic results, potentially leading to inappropriate medical treatment.
Electromagnetic contactors in FDR Visionary Suite X-ray generator cabinets may stay powered after shutdown, risking overheating and fire. 16 units affected in eight US states.
Olympus is recalling 4,183 Single Use 3-Lumen Sphincterotome V devices because some units did not undergo thermoforming, which could cause deformation and loss of performance.
Olympus recalls approximately 125 units of the Disposable Triple Lumen Sphincterotome (Model KD-411Q-0720) worldwide due to thermoforming defects that could cause device deformation and loss of performance.
Vortex Surgical is recalling its I2 Injection Kits (model VS0500) due to potential voids in pouch seals that could compromise the sterile barrier and cause infection. Affected are 14,789 units distributed nationwide and internationally.
Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.
VANTIVE US HEALTHCARE is recalling 13,760 PRISMAFLEX TPE2000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.
Vantive US Healthcare is recalling the Prismaflex HF1000 SET dialyzer due to a potential dislodgement of the deaeration chamber from the control unit. The recall affects 93,576 units distributed nationwide.
Encore Medical recalled EMPOWR 3D Knee Tibial Insert devices and other orthopedic implants due to packaging discrepancies that may deliver wrong devices, potentially requiring surgical delay or revision procedures.
Multiple brands of UTI test strips have been recalled for distribution before FDA clearance. The strips may produce false or inaccurate results that could lead to inappropriate medical decisions.
Siemens is removing three software applications from SOMATOM X.ceed CT systems worldwide because they lack FDA 510(k) clearance. Affected units are being recalled to ensure regulatory compliance.
Olympus Corporation is recalling the KD-640L electrosurgical knife nationwide due to deterioration causing overheating, burning, and tip breakage risk during surgery.
Diagnostic test strips for S. Typhi and Para Typhi A antigens were distributed without FDA approval and may provide inaccurate results, potentially leading to inappropriate medical intervention.
VANTIVE US Healthcare is recalling 264,040 PRISMAFLEX ST150 dialyzers nationwide due to potential dislodgement of the deaeration chamber from the control unit during use.
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Fujirebio Diagnostics is recalling the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test because it may produce falsely elevated positive or indeterminate results, causing patients to be incorrectly classified as having Alzheimer's disease or requiring unnecessary further testing.
Fujirebio Diagnostics is recalling Lumipulse β-Amyloid Plasma Controls due to falsely elevated test results that may cause incorrect classification of Alzheimer's disease status. The quality control product may provide false positive or unnecessary indeterminate results.
Vortex Surgical is recalling Oertli laser probes due to voids in Tyvek pouches that could compromise the sterile barrier and lead to infection risk.
Vortex Surgical is recalling its 25GA Internal Delivery Device due to voids in pouch seals that may compromise sterility, allowing potential bacterial contamination that could lead to infection.
FDA is recalling Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges due to inaccurate test results that may falsely classify patients as having Alzheimer's disease pathology or requiring unnecessary clinical testing.
Siemens is recalling software applications used in NAEOTOM Alpha CT systems because they lack FDA 510(k) clearance. The recall affects 88 units.