FDA Medical Device Recalls (openFDA)
Alcon Research, LTD.: Alcon Custom Pak
- Recall number
- Z-0053-2018
- Recalling firm
- Alcon Research, LTD.
- Product
- Alcon Custom Pak
- Status
- Terminated
- Initiated
- 2017-08-08
- Posted
- 2017-08-25
- Terminated
- 2019-08-05
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
- Quantity
- 33 units
- Distribution
- States in the US - WI, NY, MO
- Lot, serial or model codes
- 2033459H, 2034186H, 2034491H
- 510(k) numbers
- ["K880961"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000117501
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28