Elevated risk U.S. Food and Drug Administration

Olympus Single use ligating device recall: PolyLoop device may fail to detach as expected and become anchored to patient

Recall published 11 months ago

PolyLoop device may fail to detach as expected and become anchored to patient anatomy

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Olympus took this action after receiving adverse event reports indicating that the Polyloop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
December 5, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Olympus
Product type
Medical devices

Products covered by this recall

Single use ligating device

What the company announced

“The firm updated the press on April 24, 2026 to inform customers of updates to their instructions for use to clarify correct handling and use.”

UPDATE: Olympus Corporation has announced an update to a medical device corrective action regarding its Single-Use Ligating Device (“PolyLoop”). Subsequent to the previous action, Olympus has updated the PolyLoop Instructions for Use (IFU) to clarify correct handling and loop-release techniques. The revised IFU includes previously issued guidance as well as supplemental explanations and illustrations intended to clarify the existing guidance. Users are asked to replace the previous IFU with the revised IFU and leaflet, “Preventing Incorrect and Incomplete Loop Detachment.”

Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device ("Polyloop") following identification of a potential safety issue.

The Polyloop device is designed for use with Olympus endoscopes to deliver a nylon loop snare intended to prevent or control bleeding following polypectomy of pedunculated polyps.

Olympus took this action after receiving adverse event reports indicating that the Polyloop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy. No deaths have been reported.

An unreleased ligation loop can present procedural challenges, requiring emergency intervention for removal from patient's anatomy. Risks include bleeding, mucosal injury, perforation, and in severe cases, the need for surgical intervention or hospitalization.

Customers were notified of the corrective action by letter in November 2025 and are asked to ensure all personnel are familiar with the supplemental illustrative guidance and existing warnings and cautions, including the emergency treatment procedure outlined in the Instructions for Use. Customers in the U.S. are asked to acknowledge receipt of the letter on the Olympus recall web portal by visiting: https://olympusamerica.com/recall and entering the recall number "0476".

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch­fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems­fda .

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email [email protected] .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Establishment number

Inside the USDA mark of inspection on the label.

  • 0476

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Olympus — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Olympus Corporation — Consumers: Olympus Technical Assistance Center, 1-800-848-9024, Option 1, [email protected] — Media: Susan Scerbo, (484) 505-0407, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus medical devices recalled?

PolyLoop device may fail to detach as expected and become anchored to patient anatomy Olympus took this action after receiving adverse event reports indicating that the Polyloop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: establishment number 0476. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

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