CLASS III ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Z-800 Infusion System Z-800WF recalled by Zyno Medical

Zyno Medical is recalling Z-800 Infusion System Z-800WF, distributed in 8 states. The recall was initiated on 30 Sep 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel/Catalog Number: Z-800WF; UDI-DI: 00814371020006; Serial Numbers: 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371, 500373, 500374, 500375, 500376, 500377, 500378, 500384, 500385, 500386, 500388, 500389, 500390, 500391, 500392, 500393, 500394, 502634, 503435, 503716, 503799, 503917, 503921, 504534, 504807, 504808, 504809, 504810, 504811, 504812, 504813, 504814, 504815, 504816, 504817, 504818, 504819, 504820, 504821, 504822, 504823, 504824, 504825, 504826, 504827, 504828, 504829, 504830, 504831, 504832, 504834, 504835, 504836, 504838, 505369, 505425, 505430, 505432, 505437, 505626, 505627, 505628, 505629, 505630, 505631, 505632, 505633, 505635, 505637, 505638, 505691, 505692, 505693, 506585, 506982, 506983,

Quantity recalled100 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-0523-2025
FDA event ID: 95635
Recalling firm: Zyno Medical, Natick, MA
Classification: Class III
Status: Ongoing
Recall initiated: 30 Sep 2024
FDA classified: 22 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Sep 2024	Recall initiated by company
22 Nov 2024	Classified by FDA	+53 days
4 Dec 2024	Published in enforcement report	+12 days

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

Reason for recall

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

Alabama Florida Louisiana Michigan Nebraska New Jersey Ohio Texas

Questions about this recall

Why was it recalled?

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Which lots are affected?

Model/Catalog Number: Z-800WF; UDI-DI: 00814371020006; Serial Numbers: 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371, 500373, 500374, 500375, 500376, 500377, 500378, 500384, 500385, 500386, 500388, 500389, 500390, 500391, 500392, 500393, 500394, 502634, 503435, 503716, 503799, 503917, 503921, 504534, 504807, 504808, 504809, 504810, 504811, 504812, 504813, 504814, 504815, 504816, 504817, 504818, 504819, 504820, 504821, 504822, 504823, 504824, 504825, 504826, 504827, 504828, 504829, 504830, 504831, 504832, 504834, 504835, 504836, 504838, 505369, 505425, 505430, 505432, 505437, 505626, 505627, 505628, 505629, 505630, 505631, 505632, 505633, 505635, 505637, 505638, 505691, 505692, 505693, 506585, 506982, 506983,

Where was it sold?

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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
27 Nov 2024Device	CLASS II	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Packaging Defects	MA

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