# Major Recall Alert: Single Use Ligating Device Recalled Due to Detachment Failure Risk
Olympus Corporation has announced a significant recall of its Single-Use Ligating Device ("Polyloop") due to a potential safety issue. This medical device, commonly used with Olympus endoscopes for controlling bleeding during procedures, may fail to detach as expected, leading to severe complications. Here’s what you need to know about this recall, its implications, and how to stay informed.
## Why This Recall is Important
Medical device recalls are no small matter, especially when they involve risks to patient safety. The Olympus PolyLoop device is designed to deliver a nylon loop snare to safely manage bleeding after a polypectomy. However, reports indicate that the device may fail to release properly, causing the loop to anchor itself unintentionally to the patient’s anatomy. This failure can lead to:
- Procedural challenges,
- Emergency intervention or removal,
- Risks such as perforation, severe bleeding, mucosal injuries,
- Even hospitalization or surgical intervention in severe cases.
While thankfully no fatalities have been reported, the issue poses serious risks to patients undergoing routine medical procedures. This recall highlights the need for immediate awareness and action to minimize harm.
## Details of the Recall
Olympus initiated a **voluntary corrective action** for the Single-Use Ligating Device on **December 5, 2025**. Here's what you need to know:
- **Issue**: PolyLoop device may fail to detach as expected, becoming anchored to patient anatomy.
- **Risks**: Bleeding, injuries to vital tissue, perforation, and potential hospitalization.
- **Product Use**: Designed for use with Olympus endoscopes during polypectomy procedures.
- **Safety Alert**: Customers were notified in November 2025 by Olympus, with supplemental guidance provided for emergency situations.
For those affected, Olympus has provided updated instructions to mitigate the risk. This includes a detailed emergency treatment procedure in the Instructions for Use, as well as enhanced training material to ensure proper handling.
## What You Should Do
If you are using Olympus’ Single-Use Ligating Device, it’s crucial to take the following steps immediately:
- **Check Affected Products**: Confirm if you have the recalled product in stock.
- **Review Safety Guidance**: Ensure all staff members are fully aware of the supplemental guidance and emergency procedures provided by Olympus.
- **Acknowledge Notification**: Visit the Olympus recall portal at [https://olympusamerica.com/recall](https://olympusamerica.com/recall) and enter the recall number "0476."
- **Report Any Issues**: Adverse reactions or quality concerns should be reported to the FDA's MedWatch program at [FDA MedWatch](https://www.fda.gov/safety/medwatchfda-safety-information-and-adverse-event-reporting-program/reporting-serious-problemsfda).
- **Contact Olympus**: For questions or to report a device-related problem, call 1-800-848-9024 (Option 1) or email complaints@olympus.com.
For the official announcement and more details, visit the [FDA recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-announces-voluntary-corrective-action-single-use-ligating-device).
## Stay Safe – Get Instant Recall Alerts
Keeping up with safety recalls is essential, whether you’re a healthcare professional or a patient. By staying informed, you can protect yourself and others from potential risks caused by defective medical devices. Download our free **Recall Alert App** today to receive real-time recall updates on Olympus medical devices and other safety issues in the U.S.!
[Download the App Now](https://myrecalls.app)
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Stay informed, stay safe, and ensure the proper checks are in place to avoid unnecessary risks. Be part of a proactive healthcare community committed to prioritizing safety.