Northeast Scientific Inc.
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Northeast Scientific Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES 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 marketing in the US.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- 2025-10-08FDA-DeviceClass IINES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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