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Olympus pulmonary endoscopes

Official notice

15 Aug 2023

Last checked

15 Aug 2023

Medium riskHealth Canada
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An official Health Canada notice concerns Olympus pulmonary endoscopes. Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal tube connector. Selection of an endotracheal tube where the size is incompatible with the Olympus airway mobilescope can result in delayed procedures, foreign body obstruction, failure to ventilate the patient, hemorrhage, upper airway tract injury, esophageal perforation, and/or airway mobilescope damage. In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is providing the following information related to using an endotracheal tube: • before inserting the airway mobilescope with an endotracheal tube into the patient, slide the tube along the entire length of the airway mobilescope insertion section to confirm that the insertion section of the airway mobilescope can be inserted smoothly into the endotracheal tube. If it cannot be inserted smoothly, the covering material of the bending section of the airway mobilescope or the external surface of the insertion section may be damaged. When using a lubricant, make the above confirmation before applying the lubricant. In the event the endotracheal tube cannot slide smoothly over the insertion section of the airway mobilescope, select another size tube, or inspect scope for damage. Olympus is undertaking this action to provide an IFU addendum which specify the correct maximum scope diameter information. Recall start date: July 28, 2023 Published 2023-08-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74122

Official notice

2023-08-15

The hazard

Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal tube connector. Selection of an endotracheal tube where the size is incompatible with the Olympus airway mobilescope can result in delayed procedures, foreign body obstruction, failure to ventilate the patient, hemorrhage, upper airway tract injury, esophageal perforation, and/or airway mobilescope damage. In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is providing the following information related to using an endotracheal tube: • before inserting the airway mobilescope with an endotracheal tube into the patient, slide the tube along the entire length of the airway mobilescope insertion section to confirm that the insertion section of the airway mobilescope can be inserted smoothly into the endotracheal tube. If it cannot be inserted smoothly, the covering material of the bending section of the airway mobilescope or the external surface of the insertion section may be damaged. When using a lubricant, make the above confirmation before applying the lubricant. In the event the endotracheal tube cannot slide smoothly over the insertion section of the airway mobilescope, select another size tube, or inspect scope for damage. Olympus is undertaking this action to provide an IFU addendum which specify the correct maximum scope diameter information. Recall start date: July 28, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

74122

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Affected products

Product 1

Affected products - Tracheal Intubation Fiberscopes, Lot or serial number - All lots., Model or catalogue number - LF-DP LF-P LF-GP LF-TP

Product 2

Affected products - Evis Exera II Ultrasonic Bronchofibervideoscope, Lot or serial number - All lots., Model or catalogue number - BF-UC180F

Product 3

Affected products - Tracheal Intubation Fiberscope, Lot or serial number - All lots., Model or catalogue number - LF-P

Product 4

Affected products - Evis Exera III Bronchofibervideoscope, Lot or serial number - All lots., Model or catalogue number - BF-MP190F

Product 5

Affected products - Airway Mobilescope, Lot or serial number - All lots., Model or catalogue number - MAF-DM2 MAF-GM2

Product 6

Affected products - Evis Eus Ultrasound Bronchofibervideoscope, Lot or serial number - All lots., Model or catalogue number - BF-UC190F

Product 7

Affected products - Airway Mobilescope- General, Lot or serial number - All lots., Model or catalogue number - MAF-GM

Product 8

Affected products - Airway Mobilescopetherapeautic, Lot or serial number - All lots., Model or catalogue number - MAF-TM

Product 9

Affected products - Evis Exera III Video System - Bronchovideoscope, Lot or serial number - All lots., Model or catalogue number - BF-1TQ180 BF-P180 BF-Q180-AC BF-Q180 BF-1T180

Product 10

Affected products - Evis Exera Video System - Bronchofibervideoscopes, Lot or serial number - All lots., Model or catalogue number - BF-MP160F BF-XP160F

Product 11

Affected products - Visera Trachael Intubation Videoscope, Lot or serial number - All lots., Model or catalogue number - LF-V

Product 12

Affected products - Evis Exera Video Sytem - Bronchovideoscope, Lot or serial number - All lots., Model or catalogue number - BF-3C160 BF-XT160

Product 13

Affected products - Oes Bronchofiberscopes, Lot or serial number - All lots., Model or catalogue number - BF-P60 BF-N20 BF-1T60 BF-XP60 BF-MP60 BF-3C40

Product 14

Affected products - Airway Mobilescope, Lot or serial number - All lots., Model or catalogue number - MAF-TM2

Risk / hazard

Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal tube connector. Selection of an endotracheal tube where the size is incompatible with the Olympus airway mobilescope can result in delayed procedures, foreign body obstruction, failure to ventilate the patient, hemorrhage, upper airway tract injury, esophageal perforation, and/or airway mobilescope damage. In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is providing the following information related to using an endotracheal tube: • before inserting the airway mobilescope with an endotracheal tube into the patient, slide the tube along the entire length of the airway mobilescope insertion section to confirm that the insertion section of the airway mobilescope can be inserted smoothly into the endotracheal tube. If it cannot be inserted smoothly, the covering material of the bending section of the airway mobilescope or the external surface of the insertion section may be damaged. When using a lubricant, make the above confirmation before applying the lubricant. In the event the endotracheal tube cannot slide smoothly over the insertion section of the airway mobilescope, select another size tube, or inspect scope for damage. Olympus is undertaking this action to provide an IFU addendum which specify the correct maximum scope diameter information. Recall start date: July 28, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Olympus Medical, Olympus Pulmonary Endoscopes

Manufacturer

Not provided

Phone

Not provided

Brand: Olympus Medical, Olympus Pulmonary Endoscopes.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74122

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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