Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
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, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Madison Polymeric Engineering is recalling the First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6. The recall involves 359 cases, totaling 10,770 kits.
The products are being recalled because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The affected lot numbers are EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181228P, EX20190103P, and EX20190105P.
The products were distributed to numerous US states, including AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI, as well as in Canada. Users should stop using the affected products and contact the recalling firm for instructions.
The recalled product
- Product
- First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
- Manufacturer
- Madison Polymeric Engineering
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 (7)
- Lot Numbers: EX20181220P
- EX20181221P
- EX20181222P
- EX20181226P
- EX20181228P
- EX20190103P
- EX20190105P
Distribution
Part of a larger recall action
This product is one of 6 recalled by Madison Polymeric Engineering 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.
See all 6 products in this recall →Related recalls
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