CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Disposable Temperature Probes, (sterile), Sensor diameter recalled
Vital Signs Devices, a GE Healthcare is recalling Disposable Temperature Probes, (sterile), Sensor diameter:/; per, distributed nationwide in the US. The recall was initiated on 18 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1959-2013
- FDA event ID
- 65857
- Recalling firm
- Vital Signs Devices, a GE Healthcare, Totowa, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2013
- FDA classified
- 13 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 18 Jul 2013 | Recall initiated by company | |
| 13 Aug 2013 | Classified by FDA | +26 days |
| 21 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Disposable Temperature Probes, (sterile), Sensor diameter:/; per recalled?
Yes. Vital Signs Devices, a GE Healthcare recalled Disposable Temperature Probes, (sterile), Sensor diameter:/; per on 18 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1959-2013.
Why was it 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 lots are affected?
GE product number M1024229
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vital Signs Devices, a GE Healthcare
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Corometrics Qwik Connect Plus Spiral Electrode recalled | Vital Signs Devices, a GE Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | enFlow IV Fluid Warmer (510k name: Eflow IV Fluid Warmer recalled | Vital Signs Devices, a GE Healthcare | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |