Device recall: Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a…

Class I FDA enforcement event 96796. Recall start date: 7 May 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Zyno Medical LLC started this device recall on 7 May 2025. The firm address in the FDA record is in Natick, MA. FDA put the recall in Class I. FDA event 96796 has 4 product records. The first FDA enforcement report date is 18 Jun 2025. The record gives the status Ongoing.

FDA enforcement report The 4 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide

Recalling firm

Zyno Medical LLC, Natick, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

4 product records in the event.

FDA event 96796: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1865-2025	Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.	613 units	Class I	Ongoing	18 Jun 2025
Z-1866-2025	Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.	613 units	Class I	Ongoing	18 Jun 2025
Z-1867-2025	Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.	613 units	Class I	Ongoing	18 Jun 2025
Z-1868-2025	Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.	613 units	Class I	Ongoing	18 Jun 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class I: 13%
Product records in this event: 4Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Zyno Medical LLC
Initiated	Product (first record)	Type	Class	Records
18 Oct 2024	Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to pr	Device	Class II	1
30 Sep 2024	Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is inte	Device	Class III	1
13 Sep 2024	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F	Device	Class I	1
4 Jun 2024	Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps	Device	Class II	1
20 Dec 2023	Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and	Device	Class II	1
29 May 2019	Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gr	Device	Class II	2
29 Jul 2016	Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-8	Device	Class II	4
13 Jun 2011	Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human pat	Device	Class II	1

Zyno Medical LLC: all 9 events

Official channels

FDA enforcement report Z-1865-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 96796. https://recallregister.com/fda/i/96796/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide
What quantity of product is in FDA event 96796?: The event has 4 product records. The first record gives this quantity: 613 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 13% of the 945 device events that started in 2025 are in Class I.