# FDA recall Z-0022-2026

> **Northeast Scientific Inc.** · Class II · device recall initiated 2025-08-29.

## Product

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154.    The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.    This model is not cleared for marketing in the US.

## Reason for recall

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

## Distribution

US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.

## Key facts

- **Recall number:** Z-0022-2026
- **Recalling firm:** Northeast Scientific Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-29
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waterbury, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2026

## Citation

> AI Analytics. FDA recall Z-0022-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0022-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*