# FDA recall Z-1521-2020

> **Avid Medical, Inc.** · Class II · device recall initiated 2020-02-18.

## Product

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

## Reason for recall

The medical procedure trays contain one or more recalled surgical gowns.  The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile.  An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

## Distribution

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

## Key facts

- **Recall number:** Z-1521-2020
- **Recalling firm:** Avid Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-18
- **Report date:** 2020-03-25
- **Termination date:** 2020-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toano, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1521-2020

## Citation

> AI Analytics. FDA recall Z-1521-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1521-2020. Source: US FDA. Licensed CC0.

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