Recall Z-1868-2025— Zyno Medical LLC

Name: FDA recall Z-1868-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Class I · Ongoing

Class I FDA medical device recall by Zyno Medical LLC, initiated 2025-05-07. It names 2 FDA 510(k) clearances: K130690, K100705. Product: Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.. Reason: Unreleased software versions were installed on distributed devices without verification or validation..

Recalling firm: Zyno Medical LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-05-07
Firm location: Natick, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K130690 — Z-800 INFUSION SYSTEMZyno Medical, LLC·cleared 2013-06-12
K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800Zyno Medical, LLC·cleared 2010-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.