a — Class II medical device recall Z-1590-2022
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-08-31, distributed nationwide. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperature
| Recall number | Z-1590-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-05-25 |
| Classified | 2022-08-25 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 00047113609126, 00300650356107, 00300650356350, 00300651356380, 20300650356354, 20300650357207, 20300650357399, 20300650358204 |
| Model numbers | 00065035604, 00065035610, 00065135658, 65035820, USSCUPA-12BUP300 |
Product
a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution Model Number: 00065035610. d. Alcon Contact Lens Solution Opti Free Replenish 2 oz. Solution Model Number: 00065135658.
Reason for recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
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-1590-2022. 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.