Public recall detail

VISERA™ Imaging System

2026-02-10

medium
General hospital and personal use - Gastroenterology and urology Performance
Quick summary

Quick summary: VISERA™ Imaging System. Reason: Performance. Category: General hospital and personal use - Gastroenterology and urology. Date: 2026-02-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: VISERA™ Imaging System. Reason: Performance. Category: General hospital and personal use - Gastroenterology and urology. Date: 2026-02-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductVISERA™ Imaging System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81587

Affected products

ProductVISERA™ Imaging System - Valve
LotAll lots.
ModelMAJ-1218
Serial numberAll lots.
DescriptionVISERA™ Imaging System - Valve
ProductBiopsy Valve
LotAll lots.
ModelMAJ-210
Serial numberAll lots.
DescriptionBiopsy Valve

Issue

Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of MAJ-210 and MAJ-1218. Olympus is highlighting the importance of strictly adhering to the IFU. Olympus will share an updated customer notification by mid-2026.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - Gastroenterology and urology
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Recall date2026-01-30
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81587
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare Industry
Source updated2026-02-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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