Severity
Moderate
FDA Devices recall · Reported November 28, 2012
There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Vital Signs Colorado Inc. recalled Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core… - a moderate-severity action.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core… was recalled by Vital Signs Colorado Inc. in November 28, 2012. Reason: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.. Check the official notice for the remedy. Verify recall #Z-0407-2013 with the FDA Devices before acting.
The recall
Vital Signs Colorado Inc. issued this moderate-severity FDA Devices recall-There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe..
Sourced from official FDA Devices enforcement records. Verify recall #Z-0407-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0407-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on August 17, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Vital Signs Colorado Inc. is listed as the recalling firm, operating out of Englewood, CO. Federal records list the affected scope as 243,685 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWIT…. 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.
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.
Severity
Moderate
Affected scope
243,685 units
Related Recalls
6
3 from same agency
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0407-2013 |
| Date reported | November 28, 2012 |
| Date initiated | August 17, 2012 |
| Recalling firm | Vital Signs Colorado Inc. |
| Firm location | Englewood, CO |
| Affected scope | 243,685 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED … |
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.
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.
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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 28, 2012. 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.