Olympus Resection Sheath, 8 mm. Model No. A42011A.… recallZ-1448-2026 · Olympus Corporation of the Americas · initiated Nov 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE CORRECTIVE ACTION notice was sent to consignees 1/6/2026. Consignees are instructed to ensure all personnel are familiar with the contents of the notification. Users are to adhere to the Inspection and Testing and Caution sections of the IFU for both the resection/inner sheath, as well as the Inspection Before Each Use section in the Resectoscope System Manual. Additional instructions include having an extra resection sheath and inspect during and after procedure for device fragments. Consignees are to retain a copy of the notification with the IFU. Consignees with any questions may contact Cynthia Ow at [email protected] or by phone at 947-999-3203.
Recall details
- Recall number
- Z-1448-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 11, 2025
- Posted by the FDA
- Feb 20, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 899 units
- Product code
- FJL
- FDA submissions
- K931995
- Distribution
- US Nationwide Distribution.
Product description
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Code information (models, lots, serial numbers)
Model No. A42011A; UDI: 04042761023658; All Lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Olympus A42011AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall963 reports
Other devices under the same FDA submission
2 devices cleared under K931995 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Olympus A22052AOLYMPUS Winter & Ibe GmbH · Resectoscope1 report
- Olympus A22053AOLYMPUS Winter & Ibe GmbH · Resectoscope1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 98288).
- Z-1438-2026 · Open, ClassifiedOlympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
- Z-1439-2026 · Open, ClassifiedOlympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
- Z-1440-2026 · Open, ClassifiedOlympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
- Z-1441-2026 · Open, ClassifiedOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
- Z-1442-2026 · Open, ClassifiedOlympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
- Z-1443-2026 · Open, ClassifiedOlympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
- Z-1444-2026 · Open, ClassifiedOlympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
- Z-1445-2026 · Open, ClassifiedOlympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- Z-1446-2026 · Open, ClassifiedOlympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
- Z-1447-2026 · Open, ClassifiedOlympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
- Z-1449-2026 · Open, ClassifiedOlympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
- Z-1450-2026 · Open, ClassifiedOlympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
- Z-1451-2026 · Open, ClassifiedOlympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
- Z-1452-2026 · Open, ClassifiedOlympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
- Z-1453-2026 · Open, ClassifiedOlympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
- Z-1454-2026 · Open, ClassifiedOlympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
- Z-1455-2026 · Open, ClassifiedOlympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Z-1456-2026 · Open, ClassifiedOlympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
- Z-1457-2026 · Open, ClassifiedOlympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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