CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
NES Reprocessed RX Turbo Elite Laser Atherectomy Catheter recalled
Northeast Scientific is recalling NES Reprocessed RX Turbo Elite Laser Atherectomy Catheter, distributed nationwide in the US. The recall was initiated on 29 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0025-2026
- FDA event ID
- 97524
- Recalling firm
- Northeast Scientific, Waterbury, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2025
- FDA classified
- 2 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 29 Aug 2025 | Recall initiated by company | |
| 2 Oct 2025 | Classified by FDA | +34 days |
| 8 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 cleared for marketing in the US.
Where it was distributed
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Nationwide CaliforniaFloridaIllinoisKansasLouisianaMarylandMichiganMissouriNorth CarolinaNew JerseyNew MexicoNevadaNew YorkPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Which lots are affected?
Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Where was it sold?
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 97524This product is part of a recall event; the main page for the event is NES Reprocessed RX Turbo Elite Laser Atherectomy Catheter recalled.
More recalls from Northeast Scientific
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NES Reprocessed OTW Turbo Elite Laser Atherectomy Catheter recalled | Northeast Scientific | Sterility | Nationwide |
| Device | CLASS II | NES Reprocessed RX Turbo Elite Laser Atherectomy Catheter recalled | Northeast Scientific | Sterility | Nationwide |
| Device | CLASS II | NES Reprocessed RX Turbo Elite Laser Atherectomy Catheter recalled | Northeast Scientific | Sterility | Nationwide |
| Device | CLASS II | NES Reprocessed OTW Turbo Elite Laser Atherectomy Catheter recalled | Northeast Scientific | Sterility | Nationwide |
| Device | CLASS II | NES Reprocessed OTW Turbo Elite Laser Atherectomy Catheter recalled | Northeast Scientific | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |