RegWardenFDA facility compliance records
Recall

Class II — Zyno Medical LLC

Recalling firmZyno Medical LLC.
Registered facilityZyno Medical LLC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonAdministration Set potential filter leaking
ProductZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
Quantity78069 sets
DistributionUS Nationwide Distribution
Initiated2016-07-29
Classified2016-09-27
Terminated2017-07-11
Recall numberZ-2894-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Zyno Medical LLC (Z-2894-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74892/

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