Skip to content

Z-800F Infusion System. Intended to provide intravenous… recallZ-1866-2025 · Zyno Medical LLC · initiated May 7, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zyno Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Unreleased software versions were installed on distributed devices without verification or validation.

FDA root cause category: Software design (manufacturing process)

What the company is doing

Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at [email protected]. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.

Recall details

Recall number
Z-1866-2025
Status
Open, Classified
Initiated by the company
May 7, 2025
Posted by the FDA
Jun 6, 2025
Recalling firm
Zyno Medical LLC
Quantity
613 units
Product code
FRN
FDA submissions
K130690, K100705
Distribution
US Nationwide

Product description

Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K130690, K100705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96796).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page