Zyno Medical LLC: FDA recalls

FDA enforcement reports name Zyno Medical LLC as the recalling firm in 9 events. The events have 16 product records. The recalls started from 2011 to 2025. All the events are device recalls.

See the 9 events

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.

Enforcement events

9 events, newest first.

FDA enforcement events of Zyno Medical LLC
Initiated	Product (first record)	Type	Class	Records	Status
7 May 2025	Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.	Device	Class I	4	Ongoing
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 provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.	Device	Class II	1	Ongoing
30 Sep 2024	Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.	Device	Class III	1	Ongoing
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 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z	Device	Class I	1	Ongoing
4 Jun 2024	Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps	Device	Class II	1	Ongoing
20 Dec 2023	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	Device	Class II	1	Ongoing
29 May 2019	Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072	Device	Class II	2	Terminated
29 Jul 2016	Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a…	Device	Class II	4	Terminated
13 Jun 2011	Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Type and class

Zyno Medical LLC: events for each product type
Type		Events
Device		9

Zyno Medical LLC: events in each class
Class		Events
Class II		6
Class I		2
Class III		1

Share of the events of the firm in Class I: 22%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 6

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.

Events by year

FDA enforcement events of Zyno Medical LLC, by the year that the recall started. The largest year is 2024, with 4 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Zyno Medical LLC: FDA recalls. https://recallregister.com/firm/zyno-medical-llc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Zyno Medical LLC have?: Class II: 6 events. Class I: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Zyno Medical LLC?: FDA event 96796, which the firm started on 7 May 2025. The first product in the record is: Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
How many FDA recalls of Zyno Medical LLC have the status Ongoing?: 6 events have the status Ongoing in the openFDA file. openFDA says 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.