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Smiths Medical has recalled ambulatory infusion pumps to provide updated use instructions to providers after identifying issues with potential false alarms as well as two other problems that could ...

A Southwest Airlines flight had to divert after a passenger's battery charger started to smoke, the day after the airline introduced new rules for devices.

The carrier will require passengers to keep lithium batteries visible while in use in order to allow flight crews to respond more quickly in case one catches fire.

The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...

ICU Medical aims to enable healthcare systems to customize infusion setups, optimizing device footprint without compromising performance or safety.

"Baxter Healthcare recalls Spectrum infusion pumps due to potential defect, leading to medication dosing issues. FDA classifies as high risk, 1 injury reported.

TORONTO (AP) — Former paramedic Peter Carlson is still having difficulty putting into perspective the shuddering jolt he and 79 others aboard Delta Air Lines flight 4819 experienced earlier this ...