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Unrated Medical device recall · FDA · Published June 19, 2018

Stryker Reprocessed Xcel Bladeless Trocar Recall: Risk of Distribution After Previous

Stryker recalls reprocessed Xcel Bladeless Trocars (H12LP) distributed after a prior recall. These endoscopic surgical tools may be in use at medical facilities. No specific remedy is stated in the recall notice.

🇺🇸 FDA recall #Z-0498-2019Medical deviceStryker ›
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Recalling firmStryker Sustainability Solutions1810 W Drake Dr · Tempe, AZ 85283-4327
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker is recalling reprocessed Xcel Bladeless Trocars (H12LP) that were distributed after a previous recall. These surgical tools are used in minimally invasive procedures. The recall occurs because the product was sent to facilities following the initial recall actions. Read more at govinfonow.com/recall/70830-stryker-reprocessed-xcel-bladeless-trocar-recall-risk-of-distribution-after.

Source Summary by GovInfoNow · govinfonow.com/recall/70830-stryker-reprocessed-xcel-bladeless-trocar-recall-risk-of-distribution-after · Updated August 21, 2026 · FDA enforcement record: FDA #Z-0498-2019

Cite this page

“Stryker Reprocessed Xcel Bladeless Trocar Recall: Risk of Distribution After Previous.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70830-stryker-reprocessed-xcel-bladeless-trocar-recall-risk-of-distribution-after. Based on FDA recall #Z-0498-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0498-2019%22&limit=1).

Why it’s dangerous

The hazard involves reprocessed trocars being distributed to facilities after a prior recall was executed. This means the product may still be in use at medical facilities despite the initial recall. The recall does not specify a mechanism for injury but indicates potential continued distribution.

Who’s affected

Medical facilities that received these reprocessed trocars after the previous recall. Surgeons and surgical teams using the affected models are most at risk.

How to tell if you have this one

Check for the model number H12LP on the trocar. Look for lot numbers listed in the recall (e.g., 3727435, 3732833, etc.). These reprocessed endoscopic trocars are used in minimally invasive surgical procedures.

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

What to do — step by step

  1. Check Product Details

    Identify the model number (H12LP) and lot numbers from the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Georgia, Illinois, Iowa, Louisiana, Maryland, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 6.4 years after the firm started it.

1. Firm started the recall: Jun 19, 201812. FDA classified it Class II: Nov 27, 201823. Published in FDA’s Enforcement Report: Dec 5, 201834. FDA terminated the recall: Nov 15, 2024420182024
  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.

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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-0498-2019 (June 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0498-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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