FDA Medical Device Recalls (openFDA)
Olympus America Inc.: Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc.
- Recall number
- Z-0107-2008
- Recalling firm
- Olympus America Inc.
- Product
- Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc.
- Status
- Terminated
- Initiated
- 2007-09-20
- Posted
- 2007-10-31
- Terminated
- 2008-02-15
- Reason
- Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- Root cause
- Process control
- Action
- The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.
- Quantity
- 153 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Model number BML-V242QR-30: Lot numbers 75K, 76K, and 77K.
- 510(k) numbers
- ["K903529"]
- PMA numbers
- not on file
- Product code
- LQC
- 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