Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H… — Class II medical device recall Z-1373-2022
Ongoing recall by Alcon Research, LLC, reported 2022-07-20, distributed in AZ, CA, MO, NY. Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
| Recall number | Z-1373-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2022-06-09 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | AZ, CA, MO, NY |
| Quantity | 320 kits |
| UPC / GTIN / UDI-DI | 10380651665238, 10380651666433, 10380651677385, 10380651684406, 10380653423096 |
Product
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
Reason for recall
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
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-1373-2022. 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.