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FDA recall, , Moderate risk

Olympus Resection and Inner Sheaths

Olympus Resection and Inner Sheaths have a ceramic tip that may break.

Summary by Recall Canary from the FDA notice

What happened

Olympus Corporation of the Americas, of Center Valley, Pennsylvania, recalled multiple models of Olympus Resection and Inner Sheaths after receiving complaints of the ceramic tip of the resection sheath breaking. The products are used in urologic and gynecological applications. The recall began on November 11, 2025, and was added to the FDA's Enforcement Report on February 20, 2026, with nationwide distribution in the United States.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

20 products

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

    UDI-DI
    • 04042761029360
    Lot code
    Model No. A22040T; UDI: 04042761029360; All Lots.

  2. Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

    UDI-DI
    • 04042761020985
    Lot code
    Model No. A22042A; UDI: 04042761020985; All Lots.

  3. Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

    UDI-DI
    • 04042761006514
    Lot code
    Model No. A4741; UDI: 04042761006514; All Lots.

  4. Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

    UDI-DI
    • 04042761020961
    Lot code
    Model No. Model No. A22041A; UDI: 04042761020961; All Lots.

  5. Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761004060
    Lot code
    Model No. A2641; UDI: 04042761004060; All Lots.

  6. Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761004176
    Lot code
    Model No. A2660; UDI: 04042761004176; All Lots.

  7. Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761023092
    Lot code
    Model No. A37004A; UDI: 04042761023092; All Lots.

  8. Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

    UDI-DI
    • 04042761020978
    Lot code
    Model No. A22041T; UDI: 04042761020978; All Lots.

  9. Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761004183
    Lot code
    Model No. A2660T; UDI: 04042761004183; All Lots.

  10. Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

    UDI-DI
    • 04042761051514
    Lot code
    Model No. WA22017A; UDI: 04042761051514; All Lots.

  11. Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

    UDI-DI
    • 04042761029339
    Lot code
    Model No. A22040A; UDI: 04042761029339; All Lots.

  12. Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

    UDI-DI
    • 04042761051521
    Lot code
    Model No. WA22017T; UDI: 04042761051521; All Lots.

  13. Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

    UDI-DI
    • 04042761004244
    Lot code
    Model No. A2666; UDI: 04042761004244; All Lots

  14. Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

    UDI-DI
    • 04042761021012
    Lot code
    Model No. A22043T; UDI: 04042761021012; All Lots.

  15. Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761004251
    Lot code
    Model No. A2666T; UDI: 04042761004251; All Lots.

  16. Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761020893
    • 04042761020909
    Lot code
    All lots.

  17. Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

    UDI-DI
    • 04042761004084
    Lot code
    Model No. A2642; UDI: 04042761004084; All Lots.

  18. Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

    UDI-DI
    • 04042761021005
    Lot code
    Model No. A22043A; UDI: 04042761021005; All Lots.

  19. Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

    UDI-DI
    • 04042761020992
    Lot code
    Model No. A22042T; UDI: 04042761020992; All Lots.

  20. Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

    UDI-DI
    • 04042761023658
    Lot code
    Model No. A42011A; UDI: 04042761023658; All Lots.

Recall details

Company began the recall
Sold in

US Nationwide Distribution.

Company
Olympus Corporation of the AmericasCenter Valley, Pennsylvania
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98288
Recall numbers
Z-1438-2026 to Z-1457-2026

All recalls from Olympus Corporation of the Americas

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)