Brand Name: Alcon Laboratories — Class I medical device recall Z-0939-2026
Ongoing recall by Alcon Research LLC, reported 2025-12-31, distributed nationwide. Ophthalmic procedure packs may have incomplete seals affecting sterility.
| Recall number | Z-0939-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2025-11-24 |
| Classified | 2025-12-23 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 151 units |
| Reason classes | sterility |
| Lot numbers | 17188-04, 17957-10, 17PJ9X, 17PJAY, 17PMWE, 17PTXP, 17PTXY, 17PU09, 19203-04, 19762-03 |
| Model numbers | 17188-04, 17957-10, 19203-04, 19762-03, 9903-20 |
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Reason for recall
Ophthalmic procedure packs may have incomplete seals affecting sterility.
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-0939-2026. 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.