Bausch & Lomb Stellaris PC w/ Laser — Class II medical device recall Z-0862-2015
Terminated recall by Bausch & Lomb Inc, reported 2014-12-31, distributed in AL, CA, CT, FL, GA, HI, IL, IN…. A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fi
| Recall number | Z-0862-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Inc, Saint Louis, MO, United States |
| Recall initiated | 2014-11-04 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-03-23 |
| Distributed | AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI, WV |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, ES, FR, GB, GR, HK, HU, IE, IN, IT, JO, MA, MY, NL, NO, PT, SE, SG, TR |
| Quantity | 106 |
| Reason classes | software |
| Serial numbers | SPC01790, SPC01791, SPC01792, SPC01793, SPC01794, SPC01795, SPC01796, SPC01797, SPC01798, SPC01799, SPC01800, SPC01801, SPC01802, SPC01803, SPC01806, SPC01807, SPC01808, SPC01809, SPC01810, SPC01811, SPC01899, SPC01900, SPC01901, SPC01902, SPC01903 and 81 more |
Product
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Reason for recall
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
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-0862-2015. 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.