Class I recallOngoing

Z-800 Infusion System recall — FDA event 96796

FDA · FDA event 96796 · Posted Jun 6, 2025

Published Jun 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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 feedback@intuvie.com.
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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Z-800 Infusion System by Zyno Medical LLC.

Products affected by FDA event 96796
Model	Description	Lot / serial range	Manufactured	Status
Z-1867-2025	Z-1867-2025	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.	Not provided in the normalized record	Ongoing
Z-1866-2025	Z-1866-2025	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; 60057	Not provided in the normalized record	Ongoing
Z-1865-2025	Z-1865-2025	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	Not provided in the normalized record	Ongoing
Z-1868-2025	Z-1868-2025	Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide
Units affected: See official FDA record
Category: Infusion pumps

Timeline

May 7, 2025
Recall initiated
Date recorded by the FDA.
Jun 6, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96796
Published: Jun 6, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

Loading MedWatcher information…

Z-800 Infusion System recall — FDA event 96796

FDA · FDA event 96796 · Posted Jun 6, 2025

Published Jun 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Z-800 Infusion System by Zyno Medical LLC.

Products affected by FDA event 96796
Model	Description	Lot / serial range	Manufactured	Status
Z-1867-2025	Z-1867-2025	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.	Not provided in the normalized record	Ongoing
Z-1866-2025	Z-1866-2025	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; 60057	Not provided in the normalized record	Ongoing
Z-1865-2025	Z-1865-2025	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	Not provided in the normalized record	Ongoing
Z-1868-2025	Z-1868-2025	Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.	Not provided in the normalized record	Ongoing

Distribution

US Nationwide

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Z-800 Infusion System recall — FDA event 96796

Follow Z-800 Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Z-800 Infusion System recall — FDA event 96796

Follow Z-800 Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline