# FDA recall Z-1295-2025

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2025-02-06.

## Product

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

## Reason for recall

Possibility for the obturator to break (separate).

## Distribution

US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.

## Key facts

- **Recall number:** Z-1295-2025
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-06
- **Report date:** 2025-03-12

- **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-1295-2025

## Citation

> AI Analytics. FDA recall Z-1295-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1295-2025. Source: US FDA. Licensed CC0.

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