The Recall Desk
HighFDA (Devices)·Z-0947-2014·Announced 2014-02-19

Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers

Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo proper endotoxin testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure in endotoxin testing for a sterile medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Ecolab Inc is recalling 6,040 individual units of Microtek Medical Bur Hole Latex Probe Covers with Gel, featuring IsoSilk, 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20. The product is manufactured by Microtek Medical, Inc., located in Columbus, MS.

The recall was initiated because certain lots of these probe covers did not undergo endotoxin (LAL) testing to the proper levels. The affected lots are distributed worldwide, including the United States (nationwide) and countries such as Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

The specific lot numbers affected by this recall are: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161. Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.

The recalled product

Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Manufacturer
Ecolab Inc
Category
Medical Device — Sterile Medical Supplies
Hazard
Affected units
6,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: D101931
  • D101981
  • D102471
  • D110561
  • D111801
  • D112301
  • D112511
  • D112991
  • D113421
  • D120191
  • D120651
  • D121521
  • D122221
  • D123401
  • D130171
  • D130311
  • D130431
  • D82061
  • D82321
  • D82871

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Ecolab Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

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Same hazard · endotoxin contamination

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