--- title: "Zyno Medical LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Zyno Medical LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/zyno-medical-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Zyno Medical LLC recall records **9** reported ongoing 9 records in this archive. Latest source date May 7, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 7, 2025 FDA device enforcement ### [Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.](https://isitonrecall.com/recall/fda-device-z-1865-2025-z-800-infusion-system-intended-to-provide-intravenous-infusion-of-parenteral-fluids-blood-and-blood/) Unreleased software versions were installed on distributed devices without verification or validation. Class I Reported ongoing Distribution: US Nationwide [Official source for Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1865-2025%22) May 7, 2025 FDA device enforcement ### [Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.](https://isitonrecall.com/recall/fda-device-z-1866-2025-z-800f-infusion-system-intended-to-provide-intravenous-infusion-of-parenteral-fluids-blood-and-blood/) Unreleased software versions were installed on distributed devices without verification or validation. Class I Reported ongoing Distribution: US Nationwide [Official source for Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1866-2025%22) May 7, 2025 FDA device enforcement ### [Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.](https://isitonrecall.com/recall/fda-device-z-1867-2025-z-800w-infusion-system-intended-to-provide-intravenous-infusion-of-parenteral-fluids-blood-and-blood/) Unreleased software versions were installed on distributed devices without verification or validation. Class I Reported ongoing Distribution: US Nationwide [Official source for Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1867-2025%22) May 7, 2025 FDA device enforcement ### [Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.](https://isitonrecall.com/recall/fda-device-z-1868-2025-z-800wf-infusion-system-intended-to-provide-intravenous-infusion-of-parenteral-fluids-blood-and-bloo/) Unreleased software versions were installed on distributed devices without verification or validation. Class I Reported ongoing Distribution: US Nationwide [Official source for Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, an...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1868-2025%22) Oct 18, 2024 FDA device enforcement ### [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, a...](https://isitonrecall.com/recall/fda-device-z-0506-2025-z-800-infusion-system-model-catalog-number-z-800-z-800f-z-800w-z-800wf-the-z-800-infusion-system-is/) Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. Class II Reported ongoing Distribution: This product is distributed only in the United States. [Official source for Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion s...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0506-2025%22) Sep 30, 2024 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-0523-2025-brand-name-z-800-infusion-system-product-name-z-800wf-model-catalog-number-z-800wf-the-z-800-infusio/) 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. Class III Reported ongoing Distribution: Domestic: AL, FL, LA, MI, NE, NJ, OH, TX. [Official source for Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0523-2025%22) Sep 13, 2024 FDA device enforcement ### [Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3....](https://isitonrecall.com/recall/fda-device-z-0005-2025-z-800-infusion-system-model-numbers-z-800-z-800f-z-800w-z-800wf-software-version-z-800-6-1-01-and-6/) There is a defect in the air-in-line software algorithm. Class I Reported ongoing Distribution: US Nationwide. [Official source for Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0005-2025%22) Jun 4, 2024 FDA device enforcement ### [Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps](https://isitonrecall.com/recall/fda-device-z-2263-2024-zyno-medical-z800-z800f-z800w-and-z800wf-infusion-pumps/) Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to ... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2263-2024%22) Dec 20, 2023 FDA device enforcement ### [Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or superv...](https://isitonrecall.com/recall/fda-device-z-1183-2024-zyno-medical-z800-large-volume-infusion-pumps-intended-to-provide-intravenous-infusion-of-parenteral/) When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated... Class II Reported ongoing Distribution: Nationwide [Official source for Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parent...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1183-2024%22) ## Reasons in these listed records - Unreleased software versions were installed on distributed devices without verification or validation. - Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. - 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. - There is a defect in the air-in-line software algorithm. These examples come from this result page and are not a ranking of every recall reason. ## Checking Zyno Medical LLC ### Is there a recall on zyno medical llc right now? This archive contains 9 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Zyno Medical LLC](https://isitonrecall.com/check/?q=Zyno%20Medical%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)