Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 10, 2019
CLEO Patient Monitor /Tranquility VS Patient Monitor
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Infinium Medical, Inc recalled CLEO Patient Monitor /Tranquility VS Patient Monitor — a moderate-severity action.
CLEO Patient Monitor /Tranquility VS Patient Monitor was recalled by Infinium Medical, Inc in July 10, 2019. Reason: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include th…. Check the official notice for the remedy. Verify recall #Z-1926-2019 with the FDA Devices before acting.
The recall
Infinium Medical, Inc issued this moderate-severity FDA Devices recall — The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include th….
- Moderate
- severity level
- 95 units
- affected scope
- Class II
- classification
- July 10, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1926-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1926-2019) was formally reported on July 10, 2019, with the manufacturer initiating the action on May 31, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Infinium Medical, Inc is listed as the recalling firm, operating out of Largo, FL. Federal records list the affected scope as 95 devices.
The documented reason for this recall is: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. Distribution data in the federal record shows the product reached: Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
95 devices
Related Recalls
6
6 from same agency
Product description
CLEO Patient Monitor /Tranquility VS Patient Monitor
Reason for recall
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1926-2019 |
| Date reported | July 10, 2019 |
| Date initiated | May 31, 2019 |
| Recalling firm | Infinium Medical, Inc |
| Firm location | Largo, FL |
| Affected scope | 95 devices |
| Distribution | Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin. |
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-1926-2019) 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? ▼
CLEO Patient Monitor /Tranquility VS Patient Monitor. Recalled by Infinium Medical, Inc. Units affected: 95 devices.
Why was this product recalled? ▼
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1926-2019.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1926-2019) 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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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 10, 2019.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.