Z-0543-05

Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive

Name: Z-0543-05 Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive
Creator: Biolase Technology Inc
Published: 2005-01-17
License: https://open.fda.gov/license/

Biolase MG LLC / initiated 2005-01-17 / Terminated

FDA source

Biolase Technology Inc began a recall of Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive on 2005-01-17. The reason FDA records is "Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0543-05
Status: Terminated
Initiated: 2005-01-17
Posted: 2005-02-15
Terminated: 2005-08-17
Recalling firm: Biolase MG LLC
Product: Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
Product code: LYB
Reason for recall: Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
FDA 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 in commerce: 206 units
Distribution: Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
Product codes and lots: Model #6200218; Serial Numbers: 10500210 to 10502680, inclusive.

Product code LYB

K031140Class IIWaterlaseBiolase Technology, Inc. / cleared 2004-07-07

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)