FDA Device recall Z-0053-2018
Alcon Custom Pak
- FDA Device
- Class II
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class II recall of Alcon Custom Pak by Alcon Research, citing 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 reca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0053-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-08 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alcon Research |
| Distribution | MO, NY, WI |
Product
Alcon Custom Pak
Reason
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.
Identifiers
| code_info | 2033459H, 2034186H, 2034491H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2018%22
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