Madison Polymeric Engineering Recalls Endoscopic Cleaning Kits Due to Microbial Contamination
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Kits due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.
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 illnesses, injuries, or hospitalizations, and the hazard is limited to microbial contamination causing odor.
Plain-English summary
Madison Polymeric Engineering is recalling the First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B. The recall involves 3 cases containing 210 kits. 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 Canada.
The recall is being conducted because the products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The specific lot number affected is EX20190103P.
The source text does not specify instructions for consumers or healthcare facilities regarding the disposal or return of the affected products.
The recalled product
- Product
- First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
- Manufacturer
- Madison Polymeric Engineering
- 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 (1)
- Lot Numbers: EX20190103P
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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