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Use caution Medical device recall · FDA · Published May 25, 2023

Boston Scientific Flexiva Pulse 242 TracTip Laser Fibers May Cause Burn Risk

Boston Scientific recalls Flexiva Pulse 242 TracTip Single-Use Laser Fibers with incorrect components that may cause overheating and burns if touched during use. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2230-2023Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers that may have incorrect components causing overheating and potential burns if touched. This recall affects specific lot numbers and expiration dates of the product. Read more at govinfonow.com/recall/57975-boston-scientific-flexiva-pulse-242-tractip-laser-fibers-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/57975-boston-scientific-flexiva-pulse-242-tractip-laser-fibers-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2230-2023

Cite this page

“Boston Scientific Flexiva Pulse 242 TracTip Laser Fibers May Cause Burn Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57975-boston-scientific-flexiva-pulse-242-tractip-laser-fibers-may-cause. Based on FDA recall #Z-2230-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2023%22&limit=1).

Boston Scientific Corporation voluntarily recalled Flexiva Pulse 242 TracTip Single-Use Laser Fibers on May 25, 2023, according to the FDA. The devices may overheat and cause burns if touched due to manufacturing defects.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Flexiva Pulse 242 TracTip Single-Use Laser Fibers
  • UPC: 08714729978664
  • Lot Numbers: 2030305543, 30305544, 30305545, 30305546, 30305547, 30305548, 30305549, 30389370, 30389371, 30389372, 30389373, 30389375, 30389376, 30389377, 30389378, 30429835, 30429837, 30479586, 30479587, 30479589, 30479590, 30521464, 30521466, 30521467, 30521468, 30554456, 30554457
  • Expiration Dates: 7-Oct-2025 to 16-Nov-2025
  • Distribution: US Nationwide and Canada

The hazard

The fibers were manufactured with incorrect components, resulting in lower power output and degradation of the aiming beam. Continued use may cause overheating of the fiber connector, which could result in a burn if touched.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Other recent recalls include Boston Scientific Imager II Angiographic Catheters (2026-08-24), Boston Scientific LUX-Dx Cardiac Monitor System (2026-08-06), and Boston Scientific StoneSmart Connect Console Power Adapters (2026-07-22). Other recent recalls of similar products include Lutronic DermaV Laser System (2026-08-06) and BD Pyxis MedStation ES Tower 352 Medication Cabinet (2026-04-30).

How to tell if you have this one

Check for lot numbers listed in the recall: 2030305543 through 30554457. The product expires between October 7, 2025 and November 16, 2025.

  • Brand
    Boston Scientific
  • Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-2228-2023Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910; GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-202566 units
Z-2229-2023Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960; GTIN: 08714729978619 Lot Number: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025339 units
Z-2230-2023Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961; GTIN: 08714729978664 Lot Numbers: 2030305543, 30305544, 30305545, 30305546, 30305547, 30305548, 30305549, 30389370, 30389371, 30389372, 30389373, 30389375, 30389376, 30389377, 30389378, 30429835, 30429837, 30479586, 30479587, 30479589, 30479590, 30521464, 30521466, 30521467, 30521468, 30554456, 30554457. Exp. Date: 7-Oct-2025 to 16-Nov-20251245 units
Z-2231-2023Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910; GTIN: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-Nov-2025112 units
Z-2232-2023Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911; GTIN: 08714729978725 Lot Numbers: 30521480, 30521485 ,30521486 Exp. Date: 20-OCT-2024 to 10-Nov-2025205 units
Z-2233-2023Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960; GTIN: 08714729978718 Lot Numbers: 30261914, 30389513, 30429863, 30429864, 30479612 Exp. Date: 02-Oct-2025 to 3-Nov-2025231 units
Z-2234-2023Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961; GTIN: 08714729978763 Lot Numbers: 30389516, 30389520, 30389525, 30429871, 30479615 Exp. Date: 20-Oct-2025 to 3-Nov-2025280 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the lot numbers on your Flexiva Pulse 242 TracTip Single-Use Laser Fibers to confirm if they are affected.

  2. Use with Caution

    If you have the affected product, avoid touching the fiber connector to prevent potential burns.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 25, 202312. FDA classified it Class II: Jul 21, 202323. Published in FDA’s Enforcement Report: Aug 2, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2230-2023 (May 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2230-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA