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 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during procedure.
Edan Diagnostics is recalling the EDAN Central Monitoring System due to potential cybersecurity issues identified by the FDA. The system manages information from EDAN medical devices.
A software update to Philips Patient Information Center iX modifies Mobile Event Notification filter settings without alerting users during upgrade. This could result in missed critical patient alerts to medical staff.
Edan Diagnostics is recalling EDAN patient monitors (X8, X10, X12 models) due to potential cybersecurity issues identified in an FDA letter. Approximately 3,824 units were distributed worldwide.
Tyber Medical is recalling a distal radius surgical plate due to incorrect thread orientation in anatomical left plates. This manufacturing defect may affect proper placement or stability of the implant.
Mazor Robotics is recalling the Mazor X robotic guidance system due to software errors that can cause incorrect surgical instrument positioning during spinal surgery. The recall affects approximately 549 systems distributed worldwide.
Beckman Coulter is recalling LDL-Cholesterol assay reagent that shows clinically significant interference from high triglyceride levels, causing measurement bias up to 28.8% in low samples and 11.02% in high samples.
Intuitive Surgical recalls 110,580 Ion Vision Probe Bags that may have compromised or incomplete sterile seals. Non-sterile devices used in surgical procedures could pose an infection risk.
Rifton Equipment is recalling approximately 1,096 Low Base TRAM powered lift devices (Model K320) due to potential fraying of the body support strap. The affected devices were distributed worldwide.
Edan Diagnostics is recalling approximately 377 EDAN iM20 Patient Monitors due to potential cybersecurity vulnerabilities identified by the FDA. No injuries have been reported.
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters because they were released before completing required quality control testing. Sterility assurance cannot be confirmed.
Merit Medical Custom Waste Management Kit Vascular Tray inflation device handles may detach from syringes during medical procedures. This Class II recall affects 864 units distributed worldwide.
Edan Diagnostics recalls EDAN fetal monitor models F2 and F3 due to potential cybersecurity issues identified by the FDA. No injuries or illnesses have been reported.
RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may fail to properly invalidate calculated radiation doses for certain region types. This could result in use of outdated dose calculations in patient treatment planning.
Edan Diagnostics is recalling EDAN Vital Signs Monitor Model M3A devices due to potential cybersecurity vulnerabilities identified by the FDA.
EDAN Diagnostics is recalling 395 units of its MFM-CNS and MFM-CNS Lite central monitoring systems following an FDA letter regarding potential cybersecurity issues.
RayStation v17.0.0 and v17.0.1 fail to properly invalidate dose calculations for certain regions of interest. The system may not recalculate radiation doses when geometry changes or material overrides are removed.
The FDA has recalled the EDAN iT20 Telemetry Transmitter due to potential cybersecurity vulnerabilities. Approximately 1,457 units were distributed across the United States and Mexico.
Philips has recalled the Azurion imaging system (Software Version R3.1) in 228 units worldwide due to two software issues that may cause loss of imaging functionality, motorized movement, incorrect image content, or data loss.
Merit Medical Systems is recalling inflation device units because the handle may detach from the syringe during medical procedures. Affected units: 4,163,123 worldwide.
RayStation radiation therapy planning software may fail to invalidate radiation dose calculations when certain regions of interest are modified. This could cause patients to be treated using outdated or incorrect dose values.
ICU Medical is recalling Tego needle-free connectors used in hemodialysis and IV administration because the silicone seal may separate or tear, potentially causing fluid leaks, therapy delays, or exposure to harmful contaminants.
Edan Diagnostics is recalling the EDAN Vital Signs Monitor Model M3 following an FDA letter regarding potential cybersecurity issues. Approximately 13,934 units were distributed in 14 U.S. states and Mexico.
RayStation radiation therapy software may fail to invalidate calculated doses in certain cases. The issue affects Regions of Interest without contours that have material overrides or specific types.
RayStation treatment planning system version 16.0.0 has a software defect preventing dose recalculation for certain region of interest configurations. The defect affects dose invalidation when specific ROI types lack contours combined with material overrides or bolus classifications.