CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report

Z-800 Infusion System recalled by Zyno Medical

Zyno Medical is recalling Z-800 Infusion System. The recall was initiated on 18 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200.

Quantity recalled34,994 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-0506-2025
FDA event ID: 95601
Recalling firm: Zyno Medical, Natick, MA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Oct 2024
FDA classified: 21 Nov 2024
Reported: 27 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

18 Oct 2024	Recall initiated by company
21 Nov 2024	Classified by FDA	+34 days
27 Nov 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

This product is distributed only in the United States.

Questions about this recall

Why was it recalled?

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Which lots are affected?

Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200.

Where was it sold?

This product is distributed only in the United States.

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

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