Olympus Recalls Inner Sheaths Used in Urological and Gynecological Procedures Due to Breakage Risk
Olympus Corporation of the Americas has issued a voluntary recall for 437 units of its Inner Sheath (Model WA22017A) following reports of ceramic tips breaking during use.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Inner Sheath, Long (Model No. WA22017A) after receiving complaints regarding the ceramic tip of the resection sheath breaking. The device is designed for use in urological and gynecological medical applications. The FDA has classified this as a Class II recall.
Which Products Are Affected
The recall affects 437 units distributed nationwide across the United States. The specific details are as follows:
- Product Name: Olympus Inner Sheath, Long
- Model Number: WA22017A
- UDI: 04042761051514
- Lot Information: All lots are included in this recall.
- Recall Number: Z-1450-2026
What You Should Do
Healthcare providers and facilities should immediately check their inventory for Model No. WA22017A. Olympus initiated the recall through a notification letter to affected customers. For further guidance on the return or management of these devices, contact Olympus Corporation of the Americas at their headquarters in Center Valley, PA.
Why This Matters
The breakage of a ceramic tip during a surgical procedure poses a risk of injury to the patient or the potential for foreign material to remain in the body, which may necessitate additional medical intervention.
Source
Information provided by the FDA (Recall Event ID: 98288).
Source: FDA Official Notice