FDA recall, , Moderate risk
Exacta Mix Vented Micro-Volume Inlet
Exacta Mix Vented Micro-Volume Inlet tubing sets may contain incorrect filters, causing reduced flow and clinical effects.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, recalled its Exacta Mix Vented Micro-Volume Inlet tubing sets because affected lots may contain incorrect 0.8-micron filters.
Using a 0.8-micron filter instead of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms, which may cause clinical effects such as electrolyte imbalance, metabolic instability, or delayed recovery.
The recall began April 22, 2026, and was added to the FDA's Enforcement Report on May 29, 2026, covering distribution in 43 states and territories.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
- Model number
- H938175
- Lot code
- 804084
- 804088
- 804089
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Taiwan and Uruguay.
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98852
- Recall number
- Z-2262-2026
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
