Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a failure to perform proper endotoxin testing, which is a quality control issue without confirmed adverse health consequences in the provided text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ecolab Inc is recalling certain lots of Microtek Medical Bur Hole Latex Free Probe Covers with Gel. The affected product is the 13cm x 244 cm (5" x 96") sterile probe cover, reference PC3688, manufactured by Microtek Medical, Inc. The recall involves 210, 560 individual units distributed nationwide in the United States and in various countries including 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 recall was initiated because certain lots of these probe covers did not undergo endotoxin (LAL) testing to the proper levels. The source text does not specify the exact nature of the defect beyond the failure to meet testing levels, nor does it report any specific illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the instructions provided by Ecolab Inc.
The recalled product
- Product
- 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
- Manufacturer
- Ecolab Inc
- Hazard
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: D100131
- D100341
- D101521
- D101861
- D101871
- D101881
- D101891
- D101901
- D101931
- D101941
- D101951
- D102491
- D102531
- D102651
- D102731
- D110691
- D110831
- D110841
- D111021
- D111111
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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