Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0019-2026 — NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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 market

U.S. FDA — Device Enforcement · United States · 2025-08-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0019-2026
Date of alert: 2025-08-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Northeast Scientific Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00850044399116

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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