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OES 4000 Hysteroscopy Sheaths, OES 4000 Urology Resectoscope System, OES Pedi...

# Major Recall Alert: OES 4000 Hysteroscopy Sheaths, OES 4000 Urology Resectoscope System, OES Pediatric Urology Sheaths, OES Pro Hysteroscopy Sheaths, OES Pro Urology Resection Sheaths, ORS 4000 Urology Resection Sheaths Recalled Due to Ceramic Tip Breakage

Olympus, a trusted name in medical devices, has issued a **major product recall** involving several of its medical instruments, including OES 4000 Hysteroscopy Sheaths, OES 4000 Urology Resectoscope System, and more. This recall stems from reports about the **ceramic tip of the resection/inner sheath breaking**, which could pose significant risks during medical procedures. Olympus is emphasizing the necessity of closely adhering to safety guidelines, including the **"inspection and testing" and "caution" sections in the Instructions for Use (IFU)** and the **"inspection before each use" section in the resectoscope system manual.**

Read on for everything you need to know about this recall, why it’s urgent, and how to protect yourself and your practice.

## Why This Recall is Important

This recall specifically highlights a **critical design issue** in the listed Olympus medical devices. The **ceramic tip of the resection/inner sheath** has been found to break, which can potentially lead to:
- **Patient injury** during procedures.
- **Delays in surgeries** or medical treatments.
- **Complications for healthcare professionals**, including unforeseen risks in the operating room.

These risks underscore the importance of proper inspection and maintenance of these devices before every use. Olympus is urging all medical professionals to follow the guidelines outlined in the product manuals as a safety measure.

## Details of the Recall

Olympus has identified complaints involving the **following products**:
- **OES 4000 Hysteroscopy Sheaths**
- **OES 4000 Urology Resectoscope System**
- **OES Pediatric Urology Sheaths**
- **OES Pro Hysteroscopy Sheaths**
- **OES Pro Urology Resection Sheaths**
- **ORS 4000 Urology Resection Sheaths**

### Key Points of Concern:
- **Reason for Recall:** The **ceramic tip of the resection/inner sheath breaking** has been reported in several incidents.
- **Safety Guidance:** Olympus highlights the importance of strictly following the **"inspection and testing" and "caution" sections** outlined in the Instructions for Use (IFU) and the resectoscope system manual.
- **Date Announced:** October 31, 31175 (as per the official announcement).

For more information, you can view the **official recall notice here**: [Government of Canada's Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/olympus-resection-and-inner-sheaths).

![Image of Recalled Products](https://myrecalls.app/images/products/31175_1768599732.jpg)

## What You Should Do

If your facility uses any of the impacted Olympus products, it is crucial to take immediate steps to mitigate potential risks:

1. **Inspect Products Before Each Use:** Follow the detailed **"inspection before each use"** section in the product’s operating manual.
2. **Adhere to Usage Guidelines:** Review the **"inspection and testing" and "cautions" sections** in the Instructions for Use (IFU) to identify possible flaws in the equipment.
3. **Contact Olympus:** Reach out to Olympus directly for further guidance or replacement options.
4. **Report Any Incidents:** Healthcare providers should report faulty devices or adverse incidents to regulatory bodies, such as Health Canada.

Failing to take action may compromise patient safety and your ability to operate safely and efficiently.

## Stay Safe – Get Instant Recall Alerts

Medical device recalls like this highlight the importance of staying updated on the latest safety issues. To ensure you never miss critical recall announcements:

- **Download the MyRecalls App:** Get real-time alerts for product recalls directly on your smartphone.
- **Stay Proactive:** Access detailed safety information, official sources, and next steps for impacted items instantly.

[Download the MyRecalls App Now!](https://myrecalls.app)

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It’s essential to act quickly to ensure the safety of your patients and team in light of this Olympus recall. For more detailed information, visit the official government recall notice here: [Recall Alert for Olympus Resection and Inner Sheaths](https://recalls-rappels.canada.ca/en/alert-recall/olympus-resection-and-inner-sheaths). Stay informed, stay safe!

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