1,030 recalls tagged with “electrical hazard”.
B Braun Medical recalled 27,480 IV extension sets on October 29, 2025. The recall affects devices tied to the Infusomat Space, Outlook, and Vista pumps. The company warns of potential medication backflow and occlusion issues that could endanger patients.
B Braun Medical recalled 11,800 IV extension sets on October 29, 2025. The recall follows reports of potential medication backflow from secondary IV containers. Healthcare providers should stop using the device immediately.
Baxter Healthcare recalled 118 units of the Welch Allyn INF BAG, Model REF 5089-18, on October 28, 2025. The replacement bladder may contain a Large Adult size bladder instead of a Thigh size bladder. This defect poses a high risk for inaccurate blood pressure readings.
Philips North America recalled 110 Azurion 7 M20 interventional fluoroscopic X-ray systems on October 27, 2025. These devices were shipped without the necessary Source-to-Skin Distance (SSD) Spacer, violating FDA regulations. The absence of this spacer poses a serious health risk during fluoroscopy applications.
Nipro Medical Corporation recalled the Surdial DX Hemodialysis System on October 27, 2025, after reports of screws loosening and potentially falling out. The recall affects devices distributed nationwide across 19 states. Patients and healthcare providers must stop using the device immediately and follow manufacturer guidance.
Siemens Medical Solutions USA recalled six MAMMOMAT Inspiration operator tables on October 24, 2025. The operator tables were sold with a bus-installation kit, which they are not designed for. This recall affects three units in the U.S. and three internationally.
Siemens Medical Solutions USA recalled one MAMMOMAT Fusion operator table on October 24, 2025. The table was sold with a bus-installation kit but is intended for stationary use only. This recall affects distribution in Arkansas, California, New York, and internationally in Australia, Canada, and India.
EDAN recalled 14,550 Patient Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models include iM50, iM60, iM70, and iM80. Healthcare providers should stop using these devices immediately and follow the manufacturer's instructions for remedy.
EDAN recalled 3,721 fetal monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models, F2 and F3, are used to monitor pregnant women and fetuses after 28 weeks of gestation. Healthcare providers must stop using these devices immediately and follow recall instructions.
EDAN recalled 395 units of its Central Monitoring System on October 24, 2025, due to potential cybersecurity risks. The affected models include MFM-CNS and MFM-CNS Lite, which manage critical fetal and maternal health data. Healthcare providers must stop using the devices immediately and follow the recall instructions.
GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.
EDAN recalled 377 iM20 Patient Monitors on October 24, 2025, due to cybersecurity issues. The recall affects devices distributed nationwide in the U.S. and Mexico. Healthcare providers must stop using this device immediately.
EDAN recalled 3,518 fetal and maternal monitors on October 24, 2025, due to potential cybersecurity issues. Affected models include F6, F9, F6 Express, and F9 Express. The recall impacts devices distributed in the U.S. and Mexico.
EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.
EDAN recalled 195 units of its Central Monitoring System MFM-CMS on October 24, 2025, due to potential cybersecurity issues. The recall follows an FDA letter warning about vulnerabilities that could impact device functionality. Users must stop using the device immediately and follow the manufacturer’s instructions for a remedy.
EDAN recalled 379 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models iX10, iX12, and iX15 pose risks to patient safety. Healthcare providers should stop using these devices immediately.
EDAN recalled 11,987 iM3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity risks. The recall affects devices distributed across the United States and Mexico.
EDAN recalled 136 vital signs monitors on October 24, 2025, due to potential cybersecurity issues. The devices include models iM3s, iM3As, iM3Bs, and iHM3s. Patients and healthcare providers must stop using these monitors immediately and follow recall instructions.
EDAN recalled 13,934 M3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity issues. The recall affects devices distributed in multiple U.S. states and Mexico. Healthcare professionals must stop using the device immediately and follow manufacturer instructions.
EDAN recalled 1,457 iT20 telemetry transmitters on October 24, 2025, due to potential cybersecurity issues. The recall affects devices distributed in the United States and Mexico. Healthcare providers and patients must immediately discontinue use of the device.