Olympus Recalls Inner Sheaths Used in Urological and Gynecological Procedures Due to Breakage Risk
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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 this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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).
Original source: FDA Official Notice ↗
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