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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65667

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ecolab Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

Z-0943-2014
Recall number
Z-0943-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
1800 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891

Distribution pattern

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.

device · product 2 of 6

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Z-0944-2014
Recall number
Z-0944-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
210, 560 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371, D121511, D121661, D121681, D122141, D122431, D122561, D122991, D130581, D81701, D81711, D82661, D83041, D83501, D90691, D90701, D91611, D92011, D92021, D92121, D92431, D92601, D92991, D93061, DA100051, DA100061, DA100341, DA100951, DA100971, DA101511, DA101521, DA102011, DA81931, DA82451, DA83011, DA83031, DA83241, DA91131,DA91141, DA91601, and DA92881

Distribution pattern

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.

device · product 3 of 6

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

Z-0945-2014
Recall number
Z-0945-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
12,546 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 4 of 6

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

Z-0946-2014
Recall number
Z-0946-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
2,102 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 5 of 6

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

Z-0947-2014
Recall number
Z-0947-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
6,040 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: 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

Distribution pattern

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.

device · product 6 of 6

Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois

Z-0948-2014
Recall number
Z-0948-2014
Initiated
July 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Ecolab Inc
Quantity
6,000 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961

Distribution pattern

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.

Field note

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