Baxter Healthcare Corporation recalls Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number:…

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 alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.

On April 22, 2026, the firm began notifying consignees via letters titled URGENT PRODUCT RECALL. Customers were instructed to locate impacted product. Customers may choose to inspect impacted inlets and continue to use those with the correct 3-micron filter, or they may choose to discard impacted inlet lots without inspection and product will be replaced.

• FDA enforcement recordOfficial FDA database entry for Z-2262-2026
• FDA 510(k) clearance · K002705The device's official FDA premarket clearance record
• FDA device classification · NEPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.