EXACTAMIX recallZ-2262-2026 · Baxter Healthcare Corporation · initiated Apr 22, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2262-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2026
- Posted by the FDA
- May 29, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 105675
- Product code
- NEP
- FDA submissions
- K002705
- Distribution
- 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.
Product description
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.
Code information (models, lots, serial numbers)
Lot Code: Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXACTAMIX H938175Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING3 recalls263 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K002705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938174Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING2 recalls238 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
- EXACTAMIX H938724EBaxter Healthcare Corporation · Set, i.V. Fluid transfer105 reports
- EXACTAMIX H938792Baxter Healthcare Corporation · Set, i.V. Fluid transfer12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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