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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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.
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