Hemospray Endoscopic Hemostat

Recalling firm
Obex Medical Ltd
Product
Hemospray Endoscopic Hemostat. [Device]. Model: HEMOSPRAY ENDOSCOPIC HEMOSTAT 7FR and HEMOSPRAY ENDOSCOPIC HEMOSTAT 10FR. Affected: Product code: G56572, G21049
Reason
The updated Hemospray Instructions for Use (IFU) will include new guidance to address endoscope adherence to the distal end of the endoscope and inability to spray powder., Instructions will be added to mitigate the occurrence of powder adhering to the distal end of the endoscope. This condition can cause the endoscope to adhere to tissue, potentially resulting in difficulty maneuvering or removing the endoscope., The Potential Complications section of the Hemospray IFU will be updated regarding powder adherence to the distal end of the endoscope.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-08-18
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/13af32d1-5441-4c51-bb07-b2142dbaed31