Reported Jun 15, 2022 · Ongoing

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

    • Hilal Embolization Microcoil
    • RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499)
    • RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Lot codes and dates
  • Lots
    • 14212811
    • 14215685
    • 14212247
    • 14212812
    • 14212814
    • 14215682
    • 14361413
    • 14361416
    • 14285326
    • 14285328
    • 14285330
    • 14297289
    • 14361412
    • 14445407
    • 14444454
    • 14477949
    • 14477950
  • UDI(01)00827002474994(17)261013(10)14212811 (01)00827002474994(17)261008(10)14215685 (01)00827002474987(17)261011(10)14212247 (01)00827002474987(17)261008(10)14212812 (01)00827002474994(17)261008(10)14212814 (01)00827002474994(17)261008(10)14215682 (01)00827002474994(17)261219(10)14361413 (01)00827002474994(17)261220(10)14361416 (01)00827002474987(17)261110(10)14285326 (01)00827002474987(17)261110(10)14285328 (01)00827002474994(17)261110(10)14285330 (01)00827002474994(17)261123(10)14297289 (01)00827002474987(17)261220(10)14361412 (01)00827002474987(17)270207(10)14445407 (01)00827002474994(17)270207(10)14444454 (01)00827002474987(17)270217(10)14477949 (01)00827002474994(17)270216(10)14477950
Amount recalled
106,033

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Cook Incorporated recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.