Vital Signs Temperature Probe Recalled for Potential Nosebleed Risk
Vital Signs Colorado Inc. is recalling 243,685 disposable temperature probes due to a potential risk of nosebleeds during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (epistaxis) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Vital Signs Colorado Inc. is recalling 243,685 units of its Disposable General Purpose 9 French Temperature Probes. These devices are used for monitoring core temperature. The recall is due to a potential for epistaxis (nosebleeds) during the use of the product.
The affected units are identified by Model Numbers 1016, 1016EU, and R1016ES, with serial numbers beginning with GXXXX64. All units made in Costa Rica are affected. Specific lot numbers are listed in the official recall documentation.
The product was distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Germany, and the United Kingdom. Consumers and healthcare providers should stop using the affected probes and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
- Manufacturer
- Vital Signs Colorado Inc.
- Hazard
- Affected units
- 243,685
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Numbers 1016
- 1016EU
- R1016ES
Distribution
Related recalls
Same manufacturer · Vital Signs Colorado Inc.
See all →- HighVital Signs LightWand Stylet Recalled for Sterile Packaging Breach
FDA (Devices) · 2015-05-06
- HighCareFusion LightWand Stylet Recalled for Sterile Packaging Breach Risk
FDA (Devices) · 2015-05-06
- SevereVital Signs Anesthesia Circuits Recalled Due to Occlusion Risk
FDA (Devices) · 2014-01-29