FDA (Devices) recall action 97524

Northeast Scientific Inc. recalled 8 products on 2025-10-08

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-10-08
Critical: 0
Units: 3,669

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2025-10-08
Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
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 no
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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 cle
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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 cl
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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 cl
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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.
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
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
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches
Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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 cle
Category
Distribution
17 states
HighFDA (Devices)··2025-10-08
Reprocessed 2.0mm laser atherectomy catheters recalled for sterile packaging breaches
Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES 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 cle
Category
Distribution
17 states