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 the agency’s own highest classification or reported deaths or serious injuries, 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
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.
Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.
Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.
Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.
Wright Medical recalls 231 EVOLVE TRIAD Plate Cutters due to sterilization failure when double-wrapped. The devices cannot be adequately sterilized, creating infection risk during surgical procedures.
Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.
Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.
Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.
Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.
Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.
Philips DigitalDiagnost C90 radiography systems have a firmware defect that may cause incorrect radiation doses and anatomic marker misalignment. The issue affects 140 systems nationwide with specific serial numbers.
Certain Philips DigitalDiagnost C90 X-ray systems contain a firmware defect that can cause incorrect radiation doses and misaligned anatomic position markers when using the Wallstand VS2 board.
Zeltiq Aesthetics is voluntarily discontinuing the CoolFit ZELTIQ Vacuum Applicator due to an increased complaint rate for the adverse event Paradoxical Hyperplasia observed during 2019-2021.
Cordis is recalling 1,089 units of PALMAZ GENESIS Transhepatic Biliary Stents due to potential stent dislodgement in two specific device sizes. Affected patients should contact their healthcare provider.
The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.
Medtronic recalls certain MiniMed 740G Insulin Pumps due to battery cap deterioration that may cause loss of power and functionality. No illnesses have been reported.