MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL… recallZ-0946-2014 · Ecolab Inc · initiated Jul 2, 2013
Class II Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ecolab Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
FDA root cause category: Process design
What the company is doing
The recall was conducted to the consumer/user level. The firm notified their direct consignees of the problem and the recall by written letter mailed on July 2, 2013. The notice requested the consignees to quarantine any recalled product on hand, and complete and return the response form by July 31, 2013. The consignees who further distributed the recalled product were asked to notify their consignees.
Recall details
- Recall number
- Z-0946-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2013
- Posted by the FDA
- Feb 10, 2014
- Recalling firm
- Ecolab Inc
- Quantity
- 2,102 individual units
- Product code
- KKX
- FDA submissions
- K882724
- Distribution
- 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.
Product description
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
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
9 devices cleared under K882724 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MICROTEK 1Microtek Medical LLC · Drape, surgical5 reports
- MICROTEK 1Microtek Medical LLC · Drape, surgical4 reports
- MICROTEK 1Microtek Medical LLC · Drape, surgical4 reports
- MICROTEK 1Microtek Medical LLC · Drape, surgical4 reports
- MICROTEK 1Microtek Medical LLC · Drape, surgical2 reports
- MICROTEK 1Microtek Medical LLC · Drape, surgical1 report
- MICROTEK 1Microtek Medical LLC · Drape, surgical1 report
- MICROTEK 1Microtek Medical LLC · Drape, surgical1 report
- MICROTEK 1Microtek Medical LLC · Drape, surgical1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 65667).
- Z-0943-2014 · TerminatedMICROTEK(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-0944-2014 · TerminatedMICROTEK(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 …
- Z-0945-2014 · TerminatedMICROTEK(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 …
- Z-0947-2014 · TerminatedMICROTEK(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-0948-2014 · TerminatedVital 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
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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