Reported Feb 12, 2020 · Terminated

Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948…

Cook Inc.

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 Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Universa Soft Ureteral Stent, Global Product No.
    • G49887
    • G49933
    • G49934
    • G49937
    • G49940
    • G49941
    • G49942
    • G49945
    • G49947
    • G49948
    • G49949
    • G49950
    • G49951
    • G49953
    • G49955
    • G49956
    • G49957
    • G49958
    • G49959
    • G49961
    • G53145
    • G53676
    • G53677
    • G53687
    • G53689
    • G53692
    • G53693
    • G53694
    • G53703
    • G53706
    • G53711
    • G53723
    • G53724
    • G53725
    • G53726
Lot codes and dates
  • 87 of 87 codes

    • 8078013
    • 8172113
    • 8001369
    • 8183381
    • NS7994828
    • 8147249
    • 8417607
    • 8600625
    • NS8417608
    • NS7990886
    • 7990888
    • 8594598
    • 8594599
    • 8056338
    • 8018675
    • 8056337
    • 8629502
    • NS8018677
    • NS8053511
    • NS8417612
    • NS8011064
    • NS8417614
    • NS8417615
    • 7998415
    • 8147267
    • 8187145
    • 8008415
    • 8011065
    • 8078026
    • 8008416
    • 8078027
    • 8078028
    • 8150465
    • 8180873
    • 8008417
    • 8033600
    • 8427840
    • 8427841
    • 8507952
    • 8507953
    • 8507954
    • 8507955
    • 7990900
    • 8003104
    • NS7990899
    • 7998422
    • 7998423
    • 8047039
    • 8056331
    • 8066970
    • 8066972
    • 8066973
    • 8066974
    • 8147295
    • 8147296
    • 8421552
    • 8427843
    • 8427847
    • 8594610
    • 7994831
Amount recalled
13388 total

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

7 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 29, 2020 · Data as of Sep 19, 6:57 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.