WaterLase iPlus Dental Laser System — Class II medical device recall Z-2263-2014
Terminated recall by Biolase Technology Inc, reported 2014-08-27, distributed nationwide. Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user inte
| Recall number | Z-2263-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biolase Technology Inc, Irvine, CA, United States |
| Recall initiated | 2014-06-12 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, DE, EG, GB, HK, IQ, IR, IT, KR, KW, NZ, PK, PL, RU, SE, SG |
| Quantity | 117 units |
| Reason classes | software |
| Serial numbers | 72110047, 72110077, 72110128, 72110263, 72110281, 72110286, 72110343, 72110469, 72110836, 72110940, 72110983, 72111060, 72120052, 72120057, 72130195, 72130260, 72130263, 72130540, 72130631, 72140014, 72140033, 72140034, 72140036, 72140037, 72140038 and 90 more |
| Model numbers | 6201463, 7200854-XX |
Product
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Reason for recall
Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2263-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.