Z-1182-2018Class II

First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of...

Name: Z-1182-2018 First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of...
Creator: Madison Polymeric Engineering
Published: 2017-11-03
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Madison Polymeric Engineering began a recall of First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross... on 2017-11-03. FDA classified it as Class II and gives the reason as "Affected lots may have exceeded its microbial limits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1182-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2018-03-26
Terminated: 2018-07-17
Recalling firm: Madison Polymeric Engineering
Product: First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: Affected lots may have exceeded its microbial limits.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Cygnus sent an Recall Letter dated November 3, 2017. Actions Required: 1. Immediately discontinue distribution of First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable). 2. Determine if any stock of the First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable) remains in your inventory. 3. Please complete the attached form and return to Cygnus Medical as indicated. 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 the lots in the tables above between November 28, 2016 and January 11, 2017 with the letter provided. Once Cygnus Medical has received your completed form, if you have indicated you have any remaining product from these lots, we will issue a Return Goods Authorization, call tag, and/or FedEx/UPS account number. If you have questions regarding this matter, please contact Customer Service at 800-990-7489 or Quality Control at 203-488-4554 at x105 during business hours 8:30am-5:00pm Eastern Standard Time.
Quantity in commerce: 285 cases
Distribution: US Distribution. .
Product codes and lots: EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1182-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1182-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

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)