Madison Polymeric Engineering: Medical Device Recall in 2018 - (Recall #: Z-1898-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6

Product Classification:

Class II

Date Initiated: March 21, 2018

Date Posted: May 30, 2018

Recall Number: Z-1898-2018

Event ID: 79826

Reason for Recall:

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Status: Terminated

Product Quantity: 359 cases/10770 kits

Code Information:

Lot Numbers: EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181228P, EX20190103P, EX20190105P

Distribution Pattern:

The products were distributed to the following US states: 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. The products were also distributed in Canada.

Voluntary or Mandated:

Voluntary: Firm initiated