Which Olympus device is affected by the Polyloop recall?

The single-use Polyloop ligating device intended for use with Olympus flexible endoscopes.

Why is the Olympus Polyloop ligating device being recalled?

Because the nylon loop may fail to detach, becoming anchored to patient anatomy and posing risks such as bleeding, perforation, or surgical removal.

Are specific lot or model numbers listed in the Olympus recall?

Olympus has not publicly listed lot numbers; facilities should treat all in-stock Polyloop devices as potentially affected unless otherwise directed by Olympus.

What immediate steps should clinicians take during the Olympus Polyloop recall?

Audit inventory, review the emergency removal procedure with staff, acknowledge the recall on the Olympus portal, and quarantine devices if instructed.

Have any deaths been linked to the Olympus Polyloop recall?

No fatalities have been reported as of the FDA notice on December 18 2025; however, several injury reports triggered the action.

How can I report an Olympus Polyloop device malfunction?

File a MedWatch report with the FDA and contact Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or complaints@olympus.com.

Will Olympus replace or credit recalled Polyloop devices?

Olympus advises contacting the Technical Assistance Center for device return authorization and information on replacement or credit options.

FDA Recall: Olympus Single use ligating device

Source: FDA

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FDA Recall: Olympus Single use ligating device

Olympus • December 18, 2025

FDA Recall Alert: Olympus Single-Use Polyloop Ligating Device Can Fail to Detach

Olympus Corporation has launched a voluntary FDA-classified recall of its single-use Polyloop ligating device after reports that the nylon loop can remain attached to tissue instead of releasing as intended. All endoscopy services using the product must audit inventory, retrain staff, and follow the emergency removal guidance outlined below.

Why the Olympus Polyloop Ligating Device Is Under FDA Recall

The Polyloop is designed to control post-polypectomy bleeding by tightening a nylon loop around the base of a pedunculated polyp. Olympus received multiple adverse-event reports indicating the loop occasionally locks on tissue and fails to detach. Potential patient risks include:

Bleeding or mucosal injury
Gastrointestinal perforation
Urgent endoscopic or surgical removal of the retained loop
Extended hospitalization

While injuries have been reported, no patient deaths were cited in the FDA notice dated December 18 2025.

Olympus Polyloop Recall: Corrective Action Steps for Healthcare Facilities

Review the Olympus customer letter (November 2025) and the accompanying illustrative guidance.
Ensure all endoscopy staff can perform the emergency removal procedure described in the Instructions for Use (IFU).
Log in to the Olympus recall portal at olympusamerica.com/recall and enter recall ID 0476 to acknowledge receipt.
Quarantine affected devices if instructed by the Olympus Technical Assistance Center.
Report any malfunctions or patient injuries to both FDA MedWatch and Olympus (contacts below).

Olympus Recall Contact Information

Olympus Technical Assistance Center
Phone: 1-800-848-9024 (Option 1)
Email: complaints@olympus.com

Media Contact
Susan Scerbo — (484) 505-0407 — sue.scerbo@olympus.com

How to Report Problems to the FDA

Submit device-related adverse events through the FDA MedWatch portal at fda.gov/medwatch.

Sources

FDA Recall Announcement

Olympus Polyloop Recall FAQ

Which Olympus device is affected by the Polyloop recall?: The single-use Polyloop ligating device intended for use with Olympus flexible endoscopes.
Why is the Olympus Polyloop ligating device being recalled?: Because the nylon loop may fail to detach, becoming anchored to patient anatomy and posing risks such as bleeding, perforation, or surgical removal.
Are specific lot or model numbers listed in the Olympus recall?: Olympus has not publicly listed lot numbers; facilities should treat all in-stock Polyloop devices as potentially affected unless otherwise directed by Olympus.
What immediate steps should clinicians take during the Olympus Polyloop recall?: Audit inventory, review the emergency removal procedure with staff, acknowledge the recall on the Olympus portal, and quarantine devices if instructed.
Have any deaths been linked to the Olympus Polyloop recall?: No fatalities have been reported as of the FDA notice on December 18 2025; however, several injury reports triggered the action.
How can I report an Olympus Polyloop device malfunction?: File a MedWatch report with the FDA and contact Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or complaints@olympus.com.
Will Olympus replace or credit recalled Polyloop devices?: Olympus advises contacting the Technical Assistance Center for device return authorization and information on replacement or credit options.

Content current as of December 18 2025. This site is independent of the FDA and Olympus.