Baxter Exactamix Pro 1200 — Class I medical device recall Z-1001-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-02-28, distributed in AL, AZ, CA, FL, GA, IA, KY, MD…. An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which
| Recall number | Z-1001-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-12-22 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI |
| Quantity | 8 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05413765588150 |
| Serial numbers | LD2339005, PLD2314002, PLD2314006, PLD2328001, PLD2328002, PLD2328004, PLD2328005, PLD2328042 |
| Model numbers | EXM12DY |
Product
Baxter Exactamix Pro 1200, REF EXM12DY
Reason for recall
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
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-1001-2024. 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.