FDA Medical Device Recalls (openFDA)
Biolase Technology Inc: Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
- Recall number
- Z-0543-05
- Recalling firm
- Biolase Technology Inc
- Product
- Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
- Status
- Terminated
- Initiated
- 2005-01-17
- Posted
- 2005-02-15
- Terminated
- 2005-08-17
- Reason
- Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
- Root cause
- Other
- Action
- Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.
- Quantity
- 206 units
- Distribution
- Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
- Lot, serial or model codes
- Model #6200218; Serial Numbers: 10500210 to 10502680, inclusive.
- 510(k) numbers
- ["K031140"]
- PMA numbers
- not on file
- Product code
- LYB
- Firm FEI
- 2027755
- Firm city
- San Clemente
- Firm state
- CA
- 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