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
Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.
Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.
Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.
Illumina is recalling 799 NextSeq 550 Dx genetic sequencers due to a cybersecurity vulnerability in the Local Run Manager software. Affected devices have been distributed worldwide and in the United States.
The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.
Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.
GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.
Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.
Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.
Medtronic is recalling HeartWare HVAD Pump Implant Kit units due to a welding defect in the center post cap that can lead to pump malfunction and affect blood flow.
GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.
GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.
Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.
Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.
GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.
Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.
Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.
The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.
Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.
Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.
GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.
GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.