Skip to content
Lower risk Medical device recall · FDA · Published August 23, 2018

Stryker LASSO NAV eco Reprocessed EP Catheters: Not Approved for Reprocessing

Stryker recalls eco reprocessed electrophysiology catheters (item # D134903) that are not approved for reprocessing, which could lead to improper use.

Take action

Contact the company

Recalling firmStryker Sustainability Solutions1810 W Drake Dr · Tempe, AZ 85283-4327
✎ GovInfoNow plain-language explainer

Stryker is recalling reprocessed electrophysiology catheters (item # D134903) because they were mistakenly labeled as approved for reprocessing when they are not. This could lead to unsafe medical use if used without proper validation. Read more at govinfonow.com/recall/69978-stryker-lasso-nav-eco-reprocessed-ep-catheters-not-approved-for.

Source Summary by GovInfoNow · govinfonow.com/recall/69978-stryker-lasso-nav-eco-reprocessed-ep-catheters-not-approved-for · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0467-2019

Cite this page

“Stryker LASSO NAV eco Reprocessed EP Catheters: Not Approved for Reprocessing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69978-stryker-lasso-nav-eco-reprocessed-ep-catheters-not-approved-for. Based on FDA recall #Z-0467-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2019%22&limit=1).

The FDA announced on 2018-08-23 that Stryker Sustainability Solutions is recalling two Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters. The hazard involves item # D134903 being distributed as item # D134909, which is not approved for reprocessing.

How to tell if you have it

  • Brand: Stryker Sustainability Solutions
  • Product: LASSO NAV eco Reprocessed Diagnostic EP Catheters
  • Item #: D134903
  • Serial Numbers: 2519054, 2534027
  • Quantity: 2 units

The hazard

Stryker Sustainability Solutions determined that the distributed catheters were item # D134909, which is not approved for reprocessing by Stryker's Sustainability Solutions Division. The record states that SSS does not create or possess labeling for item # D134909 and did not receive labeling from the manufacturer.

Context

GovInfoNow's records show Stryker Sustainability Solutions has 22 other recalls on record since 2017-12-01. Recent brand recalls include the Stryker XCEL Bladeless Trocar W/Optiview (2026-08-19) and the Bard EP XT Decapolar Catheter (2026-08-18). Other recent recalls of similar products include the ReCor Paradise Ultrasound Renal Denervation System (2026-01-29), the Paradise Ultrasound Renal Denervation Catheter (2026-01-29), and the Medline Angio Cath Pack Kits (2026-02-25).

How to tell if you have this one

Check for item number D134903 on the catheter packaging or labels. These catheters were sold with serial numbers 2519054 and 2534027.

  • Brand
    Stryker Sustainability Solutions
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for item number D134903 on the catheter packaging or labels.

Where it went and when

Where it was distributed

Distributed in Kansas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: KS OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Kansas.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Aug 23, 201812. FDA classified it Class II: Nov 14, 201823. Published in FDA’s Enforcement Report: Nov 21, 201834. FDA terminated the recall: Feb 4, 2021420182021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

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-0467-2019 (August 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0467-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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