Exact FDA event identifier

Event 96796

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 07, 2025
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Zyno Medical LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1865-2025

Recall number: Z-1865-2025
Initiated: May 07, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Zyno Medical LLC
Quantity: 613 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Code: Model Number; Z800; UDI-DI: 00814377102006; Serial No.: 800242; 801925; 802867; 900875; 901058; 901089; 901101; 901126; 901143; 901567; 904021; 904073; 800378; 801950; 803020; 900914; 901061; 901090; 901102; 901129; 901145; 901795; 904023; 904083; 801082; 802113; 803268; 900961; 901066; 901091; 901103; 901130; 901230; 904004; 904026; 904087; 801353; 802131; 803526; 900964; 901070; 901092; 901110; 901131; 901240; 904006; 904027; 904093; 801420; 802160; 803768; 901001; 901076; 901093; 901112; 901132; 901241; 904007; 904028; 904094; 801503; 802645; 900029; 901014; 901077; 901094; 901113; 901133; 901244; 904009; 904029; 905077; 801601; 802753; 900035; 901024; 901081; 901095; 901115; 901134; 901245; 904011; 904030; 905162; 801640; 802764; 900051; 901041; 901083; 901096; 901116; 901136; 901246; 904012; 904031; 906681; 801852; 802771; 900115; 901054; 901085; 901097; 901117; 901138; 901249; 904013; 904038; 906692; 801855; 802774; 900133; 901055; 901086; 901098; 901118; 901140; 901250; 904014; 904040; 906693; 801881; 802780; 900147; 901056; 901087; 901099; 901119; 901141; 901252; 904018; 904042; 906716; 801884; 802798; 900569; 901057; 901088; 901100; 901123; 901142; 901255; 904020; 904053; 906720;906721.

Distribution pattern

US Nationwide

device · product 2 of 4

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

Z-1866-2025

Recall number: Z-1866-2025
Initiated: May 07, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Zyno Medical LLC
Quantity: 613 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide

device · product 3 of 4

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

Z-1867-2025

Recall number: Z-1867-2025
Initiated: May 07, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Zyno Medical LLC
Quantity: 613 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.

Distribution pattern

US Nationwide

device · product 4 of 4

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

Z-1868-2025

Recall number: Z-1868-2025
Initiated: May 07, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Zyno Medical LLC
Quantity: 613 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.

Distribution pattern

US Nationwide