FDA Device recall Z-1001-2024
Baxter Exactamix Pro 1200, REF EXM12DY
- FDA Device
- Class I
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class I recall of Baxter Exactamix Pro 1200, REF EXM12DY by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-22 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI |
Product
Baxter Exactamix Pro 1200, REF EXM12DY
Reason
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.
Identifiers
| code_info | UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2024%22
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