Bausch + Lomb Stellaris Elite Vision Enhancement System — Class II medical device recall Z-3266-2018
Terminated recall by Bausch & Lomb Inc, reported 2018-10-03, distributed in AL, AZ, CA, CO, FL, GA, HI, IL…. The back cap separates from the body of the vitrectomy cutter.
| Recall number | Z-3266-2018 |
|---|---|
| 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 | 2018-08-08 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2019-08-28 |
| Distributed | AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WV |
| Countries outside the US | CH, ES, FR, GB, GR, HU, IL, IT, JO, MY, NL, PL, RO, RU, SG, TH |
| Quantity | 16 cases |
| UPC / GTIN / UDI-DI | 00757770059447 |
| Lot numbers | W0861, W1115 |
| Model numbers | BL5626, E5420M |
| Expiration dates | 2019-06-04, 2019-07-05 |
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
Reason for recall
The back cap separates from the body of the vitrectomy cutter.
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-3266-2018. 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.