Health Canada2 Oct 2026
PENTAX Medical ultrasound endoscopes and water bottle assembly
Health Canada published a recall notice for PENTAX Medical ultrasound endoscopes and water bottle assembly on 2 Oct 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 2 Oct 2026
- Recall type
- Health product recall
- Companies
- Pentax Medical Corporation · 1-1-110 Tsutsujigaoka, Tokyo, Tokyo-To, Japan, 196-0012
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: Pentax Medical has received an information related to a reported patient death in connection with a case in which air unintentionally entered the balloon attached to the distal end of an ultrasound endoscope during an endoscopic ultrasonography procedure.As a result of the investigation, a definitive causal relationship between the ingress of air into the balloon and the patient's death could not be established. However, it also cannot be completely ruled out. Therefore, to clearly address this potential risk, Pentax Medical has added a new warning to the IFU for the relevant ultrasound endoscopes and the water bottle assembly. This additional warning will be included in the IFU of all newly manufactured devices. For devices already placed on the market the users shall add this field safety notice to their documentation and inform their staff accordingly.As this issue may, under certain circumstances, potentially lead to a serious adverse event, Pentax Medical provides the following information to all customers using ultrasound endoscopes to ensure continued safe use of our products. Additional information Details Original published date: 2026-10-02 Affected products: Affected products Lot or serial number Model or catalogue number Water Bottle Assembly All lots. OS-H5 Ultrasound Endoscope All lots. EG34-J10U Ultrasound Endoscope All lots. EG38-J10UT Ultrasound Endoscope All lots. EG-3270UK Ultrasound Endoscope All lots. EG36-J10UR Ultrasound Endoscope All lots. EG-3670URK Ultrasound Endoscope All lots. EG-3870UTK Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.