# FDA recall Z-2331-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-06-07.

## Product

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

## Reason for recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

## Distribution

Domestic: NY, OH, & DC.

## Key facts

- **Recall number:** Z-2331-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-07
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2024

## Citation

> AI Analytics. FDA recall Z-2331-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2331-2024. Source: US FDA. Licensed CC0.

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