Device safety informationMHRA
Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE safety warning over a malfunction
The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified product(s).
What to do now
Suzhou Surgicare disposable Hysteroscopy Sheath– Recall may stop working properly or fail during use.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/001). Quoted as issued.
Summary
The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified product(s).
The risk
Device details Device name: Disposable Hysteroscopy Sheath Affected lot serial numbers: All
Advice for healthcare professionals
Review your inventory and determine if you have any affected devices.
Immediately stop use, quarantine and stop supply of any identified product(s)
Return unused stock to the distributor HJ Medical (GyneVision)
Providers should ensure all relevant members of staff receive this safety information and that they understand the problem and actions to be taken.
Report any suspected or actual adverse incidents involving these devices. There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card website or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
There is no advice for healthcare professionals to provide to patients regarding this DSI
There is no advice for distributors regarding this DSI
Advice for patients
There is no advice for healthcare professionals to provide to patients regarding this DSI
Open the MHRA notice
Questions
Why has Suzhou Surgicare disposable Hysteroscopy Sheath– Recall been recalled?
Suzhou Surgicare disposable Hysteroscopy Sheath– Recall may stop working properly or fail during use. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.