Reported Feb 19, 2014 · Terminated

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688,…

Ecolab 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: Ecolab Inc · 370 Wabasha St N · Saint Paul, MN · 55102

Is this the product you have?

  • MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Lot codes and dates
  • Lot Numbers
    • D102471
    • D102661
    • D102701
    • D110831
    • D111101
    • D111151
    • D111231
    • D111441
    • D112301
    • D112851
    • D112991
    • D113551
    • D120821
    • D121181
    • D121951
    • D122421
    • D130171
    • D130381
    • D82321
    • D82871
    • D83261
    • D90261
    • D91671
    • DA102491
    • DA90491
    • DA90621
    • DA91061
    • and DA91671
Amount recalled
2,102 individual units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

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

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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 14, 2014 · Data as of Sep 19, 4:50 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.