Z-0108-2008

Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc

Name: Z-0108-2008 Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc
Creator: Olympus America Inc.
Published: 2007-09-20
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2007-09-20 / Terminated / root cause: manufacturing process

FDA source

Olympus America Inc. began a recall of Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc on 2007-09-20. The reason FDA records is "Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0108-2008
Status: Terminated
Initiated: 2007-09-20
Posted: 2007-10-31
Terminated: 2008-02-15
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.
Product code: LQC Lithotriptor, Biliary Mechanical
Reason for recall: Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
Root cause tag: manufacturing process
FDA 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 in commerce: 37 units
Distribution: Nationwide
Product codes and lots: Model number BML-201Q: Lot numbers 76K and 77K.

Product code LQC

K903529Class IIBml SeriesOlympus Corp. / cleared 1991-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)