Z-800W Infusion System. Intended to provide intravenous… recallZ-1867-2025 · Zyno Medical LLC · initiated May 7, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zyno Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Unreleased software versions were installed on distributed devices without verification or validation.
FDA root cause category: Software design (manufacturing process)
What the company is doing
Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at [email protected]. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.
Recall details
- Recall number
- Z-1867-2025
- Status
- Open, Classified
- Initiated by the company
- May 7, 2025
- Posted by the FDA
- Jun 6, 2025
- Recalling firm
- Zyno Medical LLC
- Quantity
- 613 units
- Product code
- FRN
- FDA submissions
- K100705, K130690
- Distribution
- US Nationwide
Product description
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Code information (models, lots, serial numbers)
Model Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Z-800WZyno Medical LLC · Pump, Infusion3 recalls31 reports
Other devices under the same FDA submission
3 devices cleared under K100705, K130690 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
Other products in the same recall event
The FDA groups related products into one recall event (event 96796).
- Z-1865-2025 · Open, ClassifiedZ-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-1866-2025 · Open, ClassifiedZ-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-1868-2025 · Open, ClassifiedZ-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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