Philips Trilogy Evo Class I recall, tidal volume discrepancy

Philips Trilogy Evo Class I recall, tidal volume discrepancy

Merit Medical DuraMax Hemodialysis Catheter Class I Recall

FDA issued a Class I recall for Merit Medical Systems DuraMax Chronic Hemodialysis Catheter due to a design defect in the 16F dual-valved splittable sheath introducer. The defect may cause the sheath to fail to split as intended during procedures, potentially resulting in hemorrhage, foreign bodies left in patients, and procedure delays. The recall affects multiple product reference numbers distributed nationwide across 25+ states.

Handy Solutions Heating Pad Recall - Burn Hazard

The FDA issued a Class I recall for 847 Handy Solutions Neck & Shoulders Heating Pads (Number: 25607) manufactured by Ninbo Unico Products Co., Ltd and distributed by Navajo Manufacturing Company. The recall was initiated due to a burn hazard where folding the pad during use causes power density to increase beyond the high limit device's sensing capability, preventing automatic power termination. Distribution was nationwide across California, Mississippi, Florida, Indiana, Louisiana, Virginia, and Texas.

Merit Medical BioFlo Recall - Class I Design Defect

FDA issued Class I recall Z-1579-2026 for Merit Medical BioFlo DuraMax Catheter (16F dual-valved splittable sheath introducer) due to a design defect that may prevent proper splitting, potentially causing hemorrhage, foreign bodies, and procedure delays. The recall affects multiple product codes and is ongoing. US nationwide distribution confirmed to healthcare facilities.

Philips Respironics Trilogy Evo O2 Ventilator Recall

FDA issued a Class I recall (Z-1615-2026) for Philips Respironics Trilogy Evo O2 continuous home-use ventilators due to a critical malfunction. Using non-pneumatic nebulizers with these devices may cause discrepancies between the set tidal volume and the tidal volume actually delivered to patients, posing serious safety risks. The recall affects devices with Software Version 1.05.15.00 distributed both nationally in the US and internationally.

FERC Gas Pipeline Orders - Tariff Acceptances, Waivers, and Project Approvals

The Federal Energy Regulatory Commission issued 50 gas pipeline orders between April 1-6, 2026, covering tariff acceptances, rate adjustments, project approvals, and waiver grants for various natural gas pipeline operators including Black Hills/Kansas Gas Utility, Alliance Pipeline, Transcontinental Gas Pipe Line, and East Tennessee Natural Gas.

Merit Medical ProGuide Chronic Dialysis Catheter Recall - Hemorrhage Risk

FDA issued a Class I recall for Merit Medical Systems ProGuide Chronic Dialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer that may not split as intended. The defect can result in hemorrhage, foreign bodies left in patients, and procedure delays. 847 units distributed nationwide across multiple states.

Erbe USA Cryoprobe Recall - Rupture Risk

FDA issued a Class I recall for Erbe USA Inc's Flexible Cryoprobe (REF: 20402-411) due to risk of rupture or burst during activation. The recall affects devices distributed nationwide across the US and Puerto Rico. Healthcare providers must immediately cease use of affected devices and return them to the manufacturer.

Merit Medical CentrosFLO Hemodialysis Catheter Recall - Design Defect

FDA issued a Class I recall for Merit Medical CentrosFLO Hemodialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer that may not split as intended. The defect may result in hemorrhage, foreign bodies remaining in the patient, and procedure delays. The recall affects multiple product codes and models distributed nationwide across at least 22 states.

Erbe Cryoprobe Recall - Rupture Risk

FDA issued a Class I recall for Erbe USA Inc. Flexible Cryoprobe (REF: 20402-401) due to risk of rupture or burst during device activation. The recall (Z-1566-2026) affects products distributed nationwide in the US including Puerto Rico. Class I is the most serious recall classification, indicating reasonable probability of serious adverse health consequences or death.