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
Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters from one lot because they were released for distribution before the required quality control release process was completed.
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.
RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Philips is recalling 228 Azurion systems on software version R3.1 over two software issues that may result in loss of imaging, loss of motorized movement, incorrect image content or loss of data.
Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
Edan Diagnostics is recalling 3,721 units of its Fetal Monitor models F2 and F3 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 395 units of its Central Monitoring System models MFM-CNS and MFM-CNS Lite after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 12,201 units of its M3A Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.
Edan Diagnostics is recalling 3,824 units of its Patient Monitor models X8, X10 and X12 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 3,518 units of its Fetal & Maternal Monitor models F6, F9, F6 Express and F9 Express after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 13,934 units of its M3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B after an FDA letter raising potential cybersecurity issues with the firm's devices.
Community Products is recalling 1,096 units of the Rifton Low Base TRAM over potential fraying on the body support strap.
Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.
ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.