CLASS I ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Z-800F Infusion System recalled by Zyno Medical
Zyno Medical is recalling Z-800F Infusion System, distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1866-2025
- FDA event ID
- 96796
- Recalling firm
- Zyno Medical, Natick, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 7 May 2025
- FDA classified
- 6 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 May 2025 | Recall initiated by company | |
| 6 Jun 2025 | Classified by FDA | +30 days |
| 18 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unreleased software versions were installed on distributed devices without verification or validation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Unreleased software versions were installed on distributed devices without verification or validation.
Which lots are affected?
Model No: Z800F; UDI-DI: 00814371020013; Serial No. 600091; 600133; 600203; 600259; 600320; 600361; 600404; 600446; 600482; 600526; 600565; 600601; 600094; 600138; 600204; 600261; 600321; 600362; 600406; 600447; 600483; 600528; 600566; 600603; 600095; 600139; 600206; 600262; 600322; 600363; 600407; 600449; 600485; 600529; 600568; 600604; 600099; 600141; 600207; 600263; 600323; 600364; 600408; 600450; 600487; 600531; 600569; 600605; 600100; 600142; 600209; 600265; 600324; 600369; 600410; 600451; 600488; 600532; 600570; 600608; 600102; 600143; 600211; 600266; 600325; 600370; 600411; 600452; 600489; 600533; 600571; 600609; 600104; 600146; 600215; 600267; 600326; 600376; 600412; 600453; 600490; 600535; 600572; 600610; 600105; 600148; 600217; 600268; 600328; 600377; 600414; 600454; 600495 600536; 600573; 600611; 600106; 600150; 600220; 600270; 600330; 600378; 600415; 600456; 600496; 600539; 600574; 600612; 600108; 600151; 600223; 600271; 600331; 600379; 600416; 600457; 600498; 600540; 600575; 600613; 600109; 600152; 600224; 600289; 600335; 600383; 600417; 600458; 600499; 600541; 600576; 600614; 600110; 600153; 600227; 600292; 600336; 600384; 600418; 600460; 600504; 600542; 600577; 600615; 600111; 600154; 600228; 600294; 600338; 600385; 600419; 600461; 600505; 600543; 600578; 600617; 600112; 600155; 600229; 600295; 600339; 600386; 600422; 600462; 600506; 600545; 600579; 600618; 600113; 600156; 600230; 600297; 600341; 600387; 600423; 600464; 600509; 600546; 600580; 600921; 600114; 600157; 600231; 600298; 600342; 600388; 600424; 600465; 600510; 600549; 600583; 601325; 600115; 600158; 600235; 600299; 600343; 600389; 600425; 600466; 600511; 600551; 600584; 601433; 600116; 600159; 600238; 600300; 600344; 600391; 600427; 600467; 600513; 600553; 600585; 601514; 600118; 600160; 600239; 600301; 600347; 600392; 600430; 600470; 600514; 600554; 600586; 601603; 600120; 600161; 600240; 600302; 600348; 600393; 600431; 600471; 600516; 600555; 600587; 601651; 600121; 600162; 600249; 600303; 600349; 600394; 600432; 600473; 600517; 600556; 600589; 602578; 600122; 600164; 600250; 600304; 600350; 600396; 600436; 600474; 600518; 600557; 600591; 602743; 600126; 600165; 600251; 600305; 600351; 600398; 600437; 600475; 600519; 600558; 600592; 602807; 600127; 600168; 600252; 600306; 600352; 600399; 600438; 600476; 600520; 600559; 600594; 603858; 600129; 600174; 600253; 600308; 600353; 600400; 600440; 600477; 600521; 600560; 600595; 604637; 600130; 600176; 600254; 600309; 600356; 600401; 600442; 600478; 600522; 600562; 600596; 605411; 600131; 600188; 600255; 600310; 600357; 600402; 600443; 600480; 600523; 600563; 600599; 605870; 600132; 600192; 600257; 600319; 600359; 600403; 600445; 600481; 600525; 600564; 600600; 605918; 605964; 606886; 607077; 607891; 608058; 608061; 608612; 613123; 614776.
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96796This product is part of a recall event; the main page for the event is Z-800 Infusion System recalled by Zyno Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Z-800 Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide | |
| CLASS I | Z-800WF Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide | |
| CLASS I | Z-800W Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
More recalls from Zyno Medical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Z-800W Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Z-800WF Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Z-800 Infusion System recalled by Zyno Medical | Zyno Medical | Device Malfunction | Nationwide |
| Device | CLASS III | Z-800 Infusion System Z-800WF recalled by Zyno Medical | Zyno Medical | Device Malfunction | 8 states |
| Device | CLASS II | Z-800 Infusion System recalled by Zyno Medical | Zyno Medical | Packaging Defects | MA |
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