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Northeast Scientific Inc.

Northeast Scientific Inc. Recalls

All product recalls associated with Northeast Scientific Inc..

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Recall Summary

Total Recalls

9

Past Year

8

Class I (Serious)

0

Most Recent

Aug 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

NES 0.9mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 0.9mm Catheter (Northeast Scientific) – Sterility Breach (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 1.4mm Catheter (Northeast Scientific) – Sterility Breach (2025)

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

FDAAug 29, 2025

Nationwide

• Northeast Scientific Inc.

NES 1.4mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES 1.7mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 2.0mm Catheter (Northeast Scientific) – Sterility Breach (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES 1.7mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES 2.0mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

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

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

Northeast Scientific Inc.: NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. ...

510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

FDAApr 26, 2021Nationwide• Northeast Scientific Inc.