# FDA recall Z-1449-2022

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2019-10-01.

## Product

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

## Reason for recall

Packaging seal integrity not validated resulting in a lack of sterility assurance.

## Distribution

United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

## Key facts

- **Recall number:** Z-1449-2022
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-01
- **Report date:** 2022-07-27
- **Termination date:** 2024-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2022

## Citation

> AI Analytics. FDA recall Z-1449-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1449-2022. Source: US FDA. Licensed CC0.

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