CLASS II Device recall · Reported 19 Feb 2014 · FDA Enforcement Report

Microtek(TM) Medical Bur Hole Latex Free Probe Cover W/ Gel recalled

Ecolab is recalling Microtek(TM) Medical Bur Hole Latex Free Probe Cover W/ Gel, featuring IsoSilk(R), 5" x, distributed nationwide in the US. The recall was initiated on 2 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V

Quantity recalled12,546 individual units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0945-2014
FDA event ID: 65667
Recalling firm: Ecolab, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2013
FDA classified: 10 Feb 2014
Reported: 19 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Jul 2013	Recall initiated by company
10 Feb 2014	Classified by FDA	+223 days
19 Feb 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 65667

Reported	Class	Recall	Company	Reason	Where
19 Feb 2014	CLASS II	Microtek(TM) Medical Bur Hole Latex Free Probe Cover recalled by Ecolab	Ecolab	Other	Nationwide
19 Feb 2014	CLASS II	Microtek(TM) Medical Bur Hole Latex Probe Cover With Gel recalled	Ecolab	Other	Nationwide
19 Feb 2014	CLASS II	Vital Care(TM) Reps Inc. Ultrasound Probe Cover recalled by Ecolab	Ecolab	Other	Nationwide
19 Feb 2014	CLASS II	Microtek(TM) Medical Bur Hole Latex Probe Cover W/ Gel recalled	Ecolab	Other	Nationwide
19 Feb 2014	CLASS II	Microtek(TM) Medical Bur Hole Latex Free Probe Cover recalled by Ecolab	Ecolab	Other	Nationwide

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