All Recalls

92,900 total recalls in our database

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.

Jun 3, 2025 Patient Monitors Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Jul 9, 2025 Other Medical Devices Nationwide View Details →

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Jul 24, 2025 Implants & Prosthetics Nationwide View Details →

The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.

Jul 16, 2025 Other Medical Devices View Details →

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

Jun 12, 2025 Diagnostic Equipment Nationwide View Details →

CX Series Combi Boiler

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

A combi (or combination) boiler is a type of gas boiler that provides both a home's hot water and central heating. The hot water can exceed the temperature set on the control panel, posing a burn hazard to users.

Aug 21, 2025 Clothing & Accessories Nationwide View Details →

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

Jul 16, 2025 Seafood Nationwide View Details →

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

Jul 16, 2025 Seafood Nationwide View Details →