Alcon Custom Pak Surgical Procedure Pack — Class II medical device recall Z-0354-2023
Ongoing recall by Alcon Research, LLC, reported 2022-12-07, distributed nationwide. Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may ren
| Recall number | Z-0354-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2022-10-31 |
| Classified | 2022-12-01 |
| Reported by FDA | 2022-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, FR, GB, IT, MX, NZ, PT |
| Quantity | 308,610 kits |
| Lot numbers | 100007214, 100011843, 100012716, 100060730, 100064778, 100072572, 100082908, 100083383, 100087432, 100104358, 100105558, 100105833, 100107426, 100108230, 100112025, 100112062, 100113409, 100128207, 100129649, 100132163, 100143249, 100143909, 100144643, 100145021, 100146193, 100165608, 100166644, 100167993, 100168055, 100173851, 100175910, 100182585, 100182784, 100188235, 100190525, 100195917, 100198117, 100198173, 100200451, 100200608 and 460 more |
Product
Alcon Custom Pak Surgical Procedure Pack
Reason for recall
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
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-0354-2023. 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.