Olympus Recalls Resection Inner Sheaths Due to Ceramic Tip Breakage
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Olympus Corporation of the Americas is recalling over 7,400 resection inner sheaths used in urologic procedures due to reports of the ceramic tip breaking.
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 Resection Inner Sheaths following reports of the ceramic tip breaking. This Class II recall was officially classified by the FDA on February 20, 2026, after the firm received complaints regarding the device's structural integrity during use.
Which Products Are Affected
The recall involves the following medical device used in urologic applications:
- Product Name: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath
- Model Number: A22040T
- UDI: 04042761029360
- Lots: All lots are affected
- Quantity: 7,426 units
- Distribution: Nationwide across the United States
What You Should Do
The firm began notifying customers of the issue via a notification letter on November 11, 2025. Healthcare facilities and providers currently using these devices should follow the specific instructions provided in the firm's letter. For further information or questions regarding the recall, the recalling firm is Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
The breakage of a ceramic tip during a urologic procedure poses a potential risk of injury to the patient or may require additional medical intervention to address the broken fragments.
Source
Information provided by the FDA under recall number Z-1440-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.