# FDA recall Z-1182-2018

> **Madison Polymeric Engineering** · Class II · device recall initiated 2017-11-03.

## 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.".

## Reason for recall

Affected lots may have exceeded its microbial limits.

## Distribution

US Distribution. .

## Key facts

- **Recall number:** Z-1182-2018
- **Recalling firm:** Madison Polymeric Engineering
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2018-04-04
- **Termination date:** 2018-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2018

## Citation

> AI Analytics. FDA recall Z-1182-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1182-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*