Brand Name: Alcon Laboratories — Class II medical device recall Z-0307-2026
Ongoing recall by Alcon Research LLC, reported 2025-11-05, distributed nationwide. Due to incomplete seals in the pouch which provide the sterile barrier.
| Recall number | Z-0307-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KR, LK, LU, MA, MX, MY, NL, NZ, PE, PH, PK, PL, PT, QA, RS, SA, SE, SK, TR, TW, ZA |
| Quantity | 330 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00380650002525, 00380650002532 |
| Lot numbers | 17CDMX, 17CMKR, 17D417 |
| Model numbers | 8065000252, 8065000253 |
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Reason for recall
Due to incomplete seals in the pouch which provide the sterile barrier.
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-0307-2026. 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.