Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 27, 2024
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, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zyno Medical LLC recalled Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-8… - a moderate-severity action.
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-8… was recalled by Zyno Medical LLC in November 27, 2024. Reason: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current des…. Check the official notice for the remedy. Verify recall #Z-0506-2025 with the FDA Devices before acting.
The recall
Zyno Medical LLC issued this moderate-severity FDA Devices recall-Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current des….
- Moderate
- severity level
- 35K units
- affected scope
- Class II
- classification
- November 27, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0506-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0506-2025) was formally reported on November 27, 2024, with the manufacturer initiating the action on October 18, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zyno Medical LLC is listed as the recalling firm, operating out of Natick, MA. Federal records list the affected scope as 34,994 units.
The documented reason for this recall is: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. Distribution data in the federal record shows the product reached: This product is distributed only in the United States.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
34,994 units
Related Recalls
6
3 from same agency
Product description
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, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
Reason for recall
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0506-2025 |
| Date reported | November 27, 2024 |
| Date initiated | October 18, 2024 |
| Recalling firm | Zyno Medical LLC |
| Firm location | Natick, MA |
| Affected scope | 34,994 units |
| Distribution | This product is distributed only in the United States. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0506-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.. Recalled by Zyno Medical LLC. Units affected: 34,994 units.
Why was this product recalled? ▼
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2024. Severity: Moderate. Recall number: Z-0506-2025.
Where was the recalled product distributed? ▼
Distribution: This product is distributed only in the United States..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0506-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 27, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.