Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health"… — Class II medical device recall Z-0095-2021
Terminated recall by Alcon Research, LLC, reported 2020-10-21, distributed nationwide. The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation
| Recall number | Z-0095-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2020-08-24 |
| Classified | 2020-10-09 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2021-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 16,971 paks |
| Reason classes | specification failure |
Product
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
Reason for recall
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
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-0095-2021. 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.