Z-800WF Infusion Pumps Recalled for Software Incompatibility Issue
Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported adverse events or injuries. The hazard is a software incompatibility issue, which is lower-risk than structural defects or contamination. Class III recalls are typically rated 1 or 2.
Plain-English summary
The Z-800WF Infusion System is an intravenous pump used to deliver medications, blood, and blood products under medical supervision. Zyno Medical LLC is recalling affected units due to incompatibility between the WiFi software and the pump's operating software, which was previously installed as part of correction Z-1183-2024.
The affected units are identified by specific serial numbers and were distributed in Alabama, Florida, Louisiana, Michigan, Nebraska, New Jersey, Ohio, and Texas.
Healthcare facilities should contact Zyno Medical LLC for instructions on managing recalled units.
The recalled product
- Product
- 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 certi
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- software-incompatibility
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 8 states:
- AL
- FL
- LA
- MI
- NE
- NJ
- OH
- TX
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27