CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report

Z800 Large Volume Infusion Pumps -Intended to provide recalled

Zyno Medical is recalling Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral, distributed nationwide in the US. The recall was initiated on 20 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00814371020037 software version 5.2.05

Quantity recalled574 units

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-1183-2024
FDA event ID: 93857
Recalling firm: Zyno Medical, Natick, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Dec 2023
FDA classified: 23 Feb 2024
Reported: 6 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

20 Dec 2023	Recall initiated by company
23 Feb 2024	Classified by FDA	+65 days
6 Mar 2024	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

When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death

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

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 00814371020037 software version 5.2.05

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Zyno Medical

All 16

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS I	Z-800F Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800W Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800WF Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Z-800 Infusion System Z-800WF recalled by Zyno Medical	Zyno Medical	Device Malfunction	8 states

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide