# FDA recall Z-0053-2018

> **Alcon Research, LTD.** · Class II · device recall initiated 2017-08-08.

## 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.

## Distribution

States in the US - WI, NY, MO

## Key facts

- **Recall number:** Z-0053-2018
- **Recalling firm:** Alcon Research, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-08
- **Report date:** 2017-11-08
- **Termination date:** 2019-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2018

## Citation

> AI Analytics. FDA recall Z-0053-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0053-2018. Source: US FDA. Licensed CC0.

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