Medical devices producer Zyno issues a recall of infusion pumps due to software concerns that lack validation
In a significant development, Zyno Medical has issued a Class I recall for certain models of their Z-800 series infusion pumps due to a software issue that could potentially cause life-threatening infusion errors[1][3][4][5]. Class I recalls indicate a situation where use of the device could cause serious injury or death.
The software problem in the Z-800 infusion pumps can lead to incorrect infusion delivery, which may result in underdosing or overdosing of critical therapies[1][3][5]. Such infusion errors pose significant risks including insufficient medication delivery to patients or potentially toxic overdoses, both of which could rapidly compromise patient safety[1][3][5].
The recall was triggered by a defect in the air-in-line software algorithm, which could cause incorrect air-in-line detection and audio alarms[1][3]. This issue could lead to peripheral intravenous catheter failure and serious injury or death[1][3].
The FDA actively monitors the recall and has issued notices to healthcare providers regarding removal or corrective actions related to the affected Z-800 pumps[1][4][5]. Zyno Medical is removing these pumps from the market to prevent further patient risk[1][5]. The FDA continues to communicate with healthcare professionals about the recall and associated risks as part of their enhanced medical device recall program initiative[5].
As of the most recent updates in July 2025, the recall affects 613 units across the U.S[6]. It is important to note that this recall started eight months after Zyno Medical removed Z-800 pumps from use due to another software issue[2]. The FDA has not mentioned any other recalls related to Baxter's Novum pump as of June 11, 2025[7].
Healthcare professionals use Zyno's Z-800, Z-800F, Z-800W, and Z-800WF pumps for intravenous infusions of parenteral fluids, blood, and blood products[1]. Zyno Medical first secured 510(k) clearance for a Z-800 pump in 2007[8]. No serious injuries or deaths have been reported due to the software issue[1].
In May, Zyno wrote to customers about a problem with the pumps and asked them to stop using certain infusion pumps[2]. The recall in September was one of several notices posted by the FDA about Z-800 pumps last year[1]. It is worth mentioning that the other Z-800 notices in 2024 were lower-risk Class II or Class III recalls[1].
The FDA has not provided any new information about the healthcare professionals who use Zyno's pumps or the 510(k) clearance for the Z-800 pump in this recall[1]. Additionally, the article does not provide information about any purchase licensing rights[1].
Sources: [1] FDA Safety Communication: Zyno Medical Recalls Certain Models of Z-800 Infusion Pumps Due to Software Issue - https://www.fda.gov/medical-devices/safety-communications/zyno-medical-recalls-certain-models-z-800-infusion-pumps-due-software-issue [2] Zyno Medical Recalls Certain Models of Z-800 Infusion Pumps Due to Software Issue - https://www.fda.gov/medical-devices/recalls-market-withdrawals-safety-alerts/zyno-medical-recalls-certain-models-z-800-infusion-pumps-due-software-issue [3] Zyno Medical Recalls Z-800 Infusion Pumps Due to Software Issue - https://www.fda.gov/medical-devices/recalls-market-withdrawals-safety-alerts/zyno-medical-recalls-z-800-infusion-pumps-due-software-issue [4] Zyno Medical Recalls Z-800 Infusion Pumps Due to Software Issue - https://www.fda.gov/medical-devices/recalls-market-withdrawals-safety-alerts/zyno-medical-recalls-z-800-infusion-pumps-due-software-issue [5] Zyno Medical Recalls Certain Models of Z-800 Infusion Pumps Due to Software Issue - https://www.fda.gov/medical-devices/safety-communications/zyno-medical-recalls-certain-models-z-800-infusion-pumps-due-software-issue [6] FDA Recall Database: Zyno Medical - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=1661401 [7] FDA Recall Database: Baxter Healthcare Corporation - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=1626472 [8] FDA Recall Database: Zyno Medical - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=1443175
- The FDA is actively monitoring the recall of Zyno Medical's Z-800 series infusion pumps due to a software issue that poses health risks.
- Zyno Medical's Z-800, Z-800F, Z-800W, and Z-800WF pumps are used in healthcare for intravenous infusions of parenteral fluids, blood, and blood products.
- The recall affects 613 units across the U.S, and it was triggered by a defect in the air-in-line software algorithm, which could cause incorrect air-in-line detection and audio alarms.
- The FDA has notified healthcare providers to take removal or corrective actions related to the affected Z-800 pumps, and Zyno Medical is removing these pumps from the market to prevent further patient risk.
- This software problem could potentially cause life-threatening infusion errors, leading to underdosing or overdosing of critical therapies, and poses significant risks to patient health and safety.
- The recall follows another software issue with the Z-800 pumps, and the FDA continues to communicate with healthcare professionals about the recall and associated risks as part of their enhanced medical device recall program initiative.
