The FDA has posted 17 enforcement recalls from Baxter Healthcare Corporation since 2025, including 6 Class I (most serious) recalls. Most recent report: Sep 30, 2026.
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect pro…
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect pro…
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect pro…
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
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.…
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…
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.