The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0005-2025·Announced 2024-10-16

Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect

Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall of a medical device. Per the severity rubric, FDA Class I recalls are classified as Critical. The defect in the air-in-line detection software algorithm directly impacts a critical patient safety feature.

Plain-English summary

Zyno Medical LLC is recalling the Z-800 Infusion System, which includes models Z-800, Z-800F, Z-800W, and Z-800WF, due to a defect in the air-in-line software algorithm. The Z-800 is an infusion pump used to deliver fluids and medications intravenously.

Approximately 34,994 units have been distributed throughout the United States. The defect affects specific software versions and lot numbers identified in the FDA recall notice.

The air-in-line detection feature is designed to alert operators to the presence of air in the IV line. A defect in the software algorithm controlling this feature could impair its ability to detect this safety issue properly. The FDA has classified this as a Class I recall, indicating a serious health hazard.

The recalled product

Product
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 3.1.32 and 3.1.64z
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion Pump
Hazard

Distribution

Distributed nationwide across the United States.

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