Z-1897-2018Class II

First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit...

Name: Z-1897-2018 First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit...
Creator: Madison Polymeric Engineering
Published: 2018-03-21
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2018-03-21 / Terminated / root cause: sterility

FDA source

Madison Polymeric Engineering began a recall of First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B on 2018-03-21. FDA classified it as Class II and gives the reason as "The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1897-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-21
Posted: 2018-05-18
Terminated: 2019-04-09
Recalling firm: Madison Polymeric Engineering
Product: First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
Quantity in commerce: 3 cases/210 kits
Distribution: 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.
Product codes and lots: Lot Numbers: EX20190103P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1897-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1895-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18
Z-1896-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18
Z-1897-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18
Z-1898-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18
Z-1899-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18
Z-1900-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-18

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)