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Northeast Scientific Inc. FDA Recalls
9 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Class IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-EClass IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES ReprocessedClass IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Class IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-EClass IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-EClass IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed TurClass IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Class IIAug 29, 2025Potential for breaches in the sterile barrier packaging, com |
| NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vesClass IIApr 26, 2021510k indicated one (1) reprocessing cycle, product not clear |