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
SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.
Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.
Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.
Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.
Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.
Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.
Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.
Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.