Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet… — Class II medical device recall Z-2262-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-06-10, distributed nationwide. Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3
| Recall number | Z-2262-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-04-22 |
| Classified | 2026-05-29 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, TW, UY |
| Quantity | 105,675 |
| UPC / GTIN / UDI-DI | 00085412475806 |
| Lot numbers | 804084, 804088, 804089 |
| Model numbers | H938175 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2262-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.