Alcon Custom Pak — Class II medical device recall Z-0053-2018
Terminated recall by Alcon Research, LTD., reported 2017-11-08, distributed in MO, NY, WI. Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ra
| Recall number | Z-0053-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Houston, TX, United States |
| Recall initiated | 2017-08-08 |
| Classified | 2017-10-27 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2019-08-05 |
| Distributed | MO, NY, WI |
| Quantity | 33 units |
Product
Alcon Custom Pak
Reason for recall
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
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-0053-2018. 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.