Exacta Mix Vented Micro-Volume Inlet Recall
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Baxter Healthcare Corporation is recalling 105,675 units of Exacta Mix Vented Micro-Volume Inlet tubing sets (model H938175) because affected lots may contain incorrect 0.8-micron filters.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
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.
Which Products Are Affected
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Lot numbers: 804084, 804088, and 804089 UDI Number: 00085412475806 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. Quantity: 105675 units Distribution: US Nationwide distribution including 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, plus Taiwan and Uruguay. Recall Number: Z-2262-2026 Classification: Class II
What You Should Do
The recall was initiated voluntarily by the firm via letter.
Why This Matters
The recall affects over 105,000 units distributed nationwide and internationally, with potential impacts on ingredient transfer efficiency during use.
Source
FDA recall Z-2262-2026 (event ID 98852)
Original source: FDA Official Notice ↗
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