The FDA has posted 81 enforcement recalls from Baxter Healthcare Corporation since 2025, including 22 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating t…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.…
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system a…
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potentia…
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Pumps were released without full testing being performed, including occlusion alarm testing.
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on…
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fev…
Firm name as filed with the FDA: “Baxter Healthcare Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.