Z-1925-2019Class II

First Step Draco Pad, Product Number EP-4D

Name: Z-1925-2019 First Step Draco Pad, Product Number EP-4D
Creator: Madison Polymeric Engineering
Published: 2019-05-08
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2019-05-08 / Terminated

FDA source

Madison Polymeric Engineering began a recall of First Step Draco Pad, Product Number EP-4D on 2019-05-08. FDA classified it as Class II and gives the reason as "This product has been contaminated with Stenotrophomonas lactiubi". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1925-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-08
Posted: 2019-07-02
Terminated: 2020-07-06
Recalling firm: Madison Polymeric Engineering
Product: First Step Draco Pad, Product Number EP-4D
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: This product has been contaminated with Stenotrophomonas lactiubi.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.
Quantity in commerce: 10570
Distribution: The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.
Product codes and lots: Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1925-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02

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)