Olympus Corporation Recalls Resection Inner Sheaths Due to Ceramic Tip Breakage Risk
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Olympus Corporation of the Americas has initiated a voluntary recall of nearly 7,000 Resection Inner Sheaths 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.
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What Happened
Olympus Corporation of the Americas has initiated a voluntary, firm-led recall of its Resection Inner Sheaths used in urologic applications. The recall was prompted by several complaints reporting that the ceramic tip of the resection sheath can break during use.
Which Products Are Affected
The recall involves the Olympus Resection Inner Sheath designed for 26 Fr. Outer Sheaths.
- Product Name: Olympus Resection Inner Sheath
- Model Number: A22040A
- UDI: 04042761029339
- Lot Information: All Lots
- Quantity: 6,949 units
- Recall Number: Z-1439-2026
The affected products were distributed nationwide throughout the United States.
What You Should Do
According to the FDA, the recalling firm initiated notification to customers via letter starting in November 2025. Healthcare providers and facilities should immediately check their inventory for Model No. A22040A. If these devices are found, users should follow the instructions provided in the firm's notification letter regarding the handling or return of the affected units. For further inquiries, contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.
Why This Matters
The breakage of a ceramic tip during a urologic procedure poses a risk of injury to the patient, including the potential for foreign material to remain in the body or the need for additional medical intervention to retrieve broken fragments.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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