Madison Polymeric Engineering: Medical Device Recall in 2018 - (Recall #: Z-1899-2018)

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:

Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

Product Classification:

Class II

Date Initiated: March 21, 2018

Date Posted: May 30, 2018

Recall Number: Z-1899-2018

Event ID: 79826

Reason for Recall:

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

Status: Terminated

Product Quantity: 23 cases/1150 kits

Code Information:

Lot Numbers: EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, EX20181229P

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