FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Recall number
- Z-1455-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Status
- Open, Classified
- Initiated
- 2025-11-11
- Posted
- 2026-02-20
- Terminated
- not on file
- Reason
- Complaints of the ceramic tip of the resection sheath breaking have been received.
- Root cause
- Under Investigation by firm
- Action
- 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 Cynthia.Ow@Olympus.com or by phone at 947-999-3203.
- Quantity
- 0 units
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Model No. A2641; UDI: 04042761004060; All Lots.
- 510(k) numbers
- ["K931995"]
- PMA numbers
- not on file
- Product code
- FJL
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28