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
Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.
Oakworks Inc is recalling 212 Ultrasound EA G2 examination tables nationwide due to stress fractures in the backrest platform that make the equipment non-operational in an inclined position.
Maquet Lucea operating room light systems are being recalled due to a potential for the light to fall in the operating room. No injuries have been reported.
Getinge Usa Sales Inc is recalling Maquet PowerLEDII OR light systems due to a potential for the light to fall in the operating room. No injuries have been reported.
Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.
Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.
Smiths Medical is recalling 31,685 HIGH PRESSURE ROTATOR infusion devices with a manufacturing defect that may cause an inadequate seal. The defect could lead to medication leaks and under-infusion.
Getinge Usa Sales Inc is recalling approximately 236,793 Maquet Hanaulux HLX3000 operating room light systems nationwide and globally due to a potential for the light system to fall in the operating room.
Getinge USA is recalling Maquet G8 and G8E operating room light systems that may fall during use. Approximately 236,793 units have been distributed nationwide and globally.
Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.
Getinge Usa Sales Inc is recalling Maquet Blueline Series 30/80 operating room light systems that may fall in the operating room. No injuries have been reported.
Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.
Cook Medical is recalling MINC+ Benchtop Incubators that may lose temperature control when exposed to static electricity on the lid, potentially causing embryo damage that could require additional medical procedures.
Becton Dickinson is recalling 5,085,120 BD PosiFlush Prefilled Saline Syringes due to an incorrect stopper that increases injection force and may trigger pump alarms.
Steris Corporation is recalling V. Mueller Universal Bandage Scissors (Model SU2014-001) due to an incorrect resin carrier in the handle cover. Pink dye residue may appear on scissors and sterilization pouches after processing.
Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.