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.
Minimum severity
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device (Model IS-30-A) due to risk that the handle may detach from the syringe during angiographic procedures.
Edan Diagnostics is recalling EDAN iX series patient monitors (models iX10, iX12, iX15) due to potential cybersecurity vulnerabilities identified by the FDA.
The FDA is recalling EDAN M3B Vital Signs Monitors due to potential cybersecurity vulnerabilities. Approximately 354 units were distributed in hospitals across the U.S. and Mexico.
MicroPort Orthopedics is recalling its HIPTURN FEM HEAD TRIAL 36MM REUSABLE hip trial component due to distribution without FDA premarket authorization required in the United States.
RayStation radiation therapy planning software version 10.1 may fail to properly invalidate radiation dose calculations when regions of interest lack contours but have material overrides or are bolus/fixation/support types.
Edan Diagnostics is recalling EDAN fetal and maternal monitors (models F6, F9, F6 Express, F9 Express) affecting 3,518 units due to potential cybersecurity vulnerabilities.
EDAN patient monitors (models iM50, iM60, iM70, iM80) are being recalled for potential cybersecurity vulnerabilities identified by the FDA.
GE Healthcare Omni Legend PET systems may produce intermittent streaking artifacts in clinical scan images visible on the acquisition console. Approximately 364 units are affected worldwide.
FDA has issued a recall for EDAN iM8 series patient monitors due to potential cybersecurity vulnerabilities identified in an IHCTOA letter. Approximately 3,141 units are affected across multiple U.S. states and Mexico.
Community Products recalls the Rifton TRAM (Model K310) powered lift device due to potential fraying on the body support strap. Approximately 3,238 units were distributed worldwide.
Edan Diagnostics is recalling EDAN elite patient monitors (V5, V6, V8 models) due to potential cybersecurity vulnerabilities. Approximately 342 units have been distributed across the United States and Mexico.
ICU Medical Plum Solo and Duo Infusion Pumps may prevent programming of a flush feature after piggyback therapy due to software limit errors. Error messages block this intended pump function.
Abbott recalls approximately 1.06 million FreeStyle Libre 3 sensors due to a manufacturing defect causing carbon buildup that may produce incorrect low glucose readings, potentially affecting diabetes management.
Abbott's FreeStyle Libre 3 Plus Sensor is being recalled due to a manufacturing issue that may cause carbon buildup in the sensor, potentially resulting in incorrect low glucose readings.
Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors due to a manufacturing defect that may cause carbon buildup, resulting in incorrect low glucose readings.
Abbott is recalling approximately 258,913 FreeStyle Libre 3 Plus Sensors due to carbon buildup that may cause incorrect low glucose readings. The affected sensors expire on 01/31/2026.
Two Philips Allura Xper FD20 X-ray systems may lack proper installation of the cooling unit drip tray, risking coolant leakage onto electrical components and potential equipment shutdown.
Philips is recalling 22 Allura Xper imaging systems because the drip tray beneath the cooling unit may not be installed or properly documented. Without it, coolant could contact electrical components and cause system shutdown.
Medline medical procedure kits containing Stryker Strykeflow 2 suction irrigators are being recalled due to a 2024 design change. Irrigation solution can travel to the handpiece and battery pack, causing leaks and vaporized saline emission resembling smoke.
Medline Industries recalls pre-operative kits containing B. Braun IV administration sets because their check valve components may become stuck in open or closed positions, potentially affecting fluid delivery.
Certain Philips Allura Xper diagnostic imaging systems may be missing a cooling unit drip tray, which could allow coolant to contact electrical components and trigger system shutdown.
A drip tray beneath the cooling unit in some Philips Allura imaging systems was not installed or not adequately documented, potentially allowing coolant to contact electrical components and cause system shutdown.
Medline medical procedure kits containing Stryker Strykeflow 2 suction irrigators are recalled. A 2024 design change causes irrigation solution to leak and vaporized saline to emit during use.
Diagnostica Stago is recalling Asserachrom HPIA diagnostic test kits (lot 271288) due to a potential defect that may produce negative test results. The kits detect antibodies associated with heparin-induced thrombocytopenia.
GE HealthCare is recalling certain MAXXUS nuclear medicine systems that may have been transported without proper detector support, potentially compromising mounting mechanisms. No injuries have been reported to date.