Madison Polymeric Engineering: Medical Device Recall in 2018 - (Recall #: Z-1182-2018)

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 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 Classification:

Class II

Date Initiated: November 3, 2017

Date Posted: April 4, 2018

Recall Number: Z-1182-2018

Event ID: 79402

Reason for Recall:

Affected lots may have exceeded its microbial limits.

Status: Terminated

Product Quantity: 285 cases

Code Information:

EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A

Distribution Pattern:

US Distribution. .

Voluntary or Mandated:

Voluntary: Firm initiated