Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 21, 2013
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs D…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vital Signs Devices, a Ge Healthcare Company recalled Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box.… - a moderate-severity action.
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box.… was recalled by Vital Signs Devices, a Ge Healthcare Company in August 21, 2013. Reason: GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 Fr…. Check the official notice for the remedy. Verify recall #Z-1959-2013 with the FDA Devices before acting.
The recall
Vital Signs Devices, a Ge Healthcare Company issued this moderate-severity FDA Devices recall-GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 Fr….
- Moderate
- severity level
- 12K units
- affected scope
- Class II
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1959-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1959-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Vital Signs Devices, a Ge Healthcare Company is listed as the recalling firm, operating out of Totowa, NJ. Federal records list the affected scope as 12,239 units (5,002 units US, 7,237 units OUS)..
The documented reason for this recall is: GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperatur… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, S…. 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
12,239 units (5,002 units US, 7,237 units OUS).
Related Recalls
6
3 from same agency
Product description
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
Reason for recall
GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1959-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 18, 2013 |
| Recalling firm | Vital Signs Devices, a Ge Healthcare Company |
| Firm location | Totowa, NJ |
| Affected scope | 12,239 units (5,002 units US, 7,237 units OUS). |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kin… |
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-1959-2013) 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? ▼
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.. Recalled by Vital Signs Devices, a Ge Healthcare Company. Units affected: 12,239 units (5,002 units US, 7,237 units OUS)..
Why was this product recalled? ▼
GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1959-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1959-2013) 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 August 21, 2013. 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.