Reported Jun 18, 2025 · Ongoing
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a…
Zyno Medical LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zyno Medical LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Lot codes and dates
- Model Number
Z800WUDI-DI00814371020020Serial No. 700063700163700203700402700488700093700169700210700428700495700104700172700214700431700503700111700188700225700440700510700120700189700230700449700513700135700190700285700460700541700145700192700375700471700481700150700195700391700472700397700159700199700393700478700201700162
- Model Number
- Amount recalled
- 613 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Unreleased software versions were installed on distributed devices without verification or validation.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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