First Step Endoscopic Cleaning Pad — Class II medical device recall Z-1898-2018
Terminated recall by Madison Polymeric Engineering, reported 2018-05-30, distributed in AK, AL, AR, CA, CT, DE, FL, GA…. The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
| Recall number | Z-1898-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Madison Polymeric Engineering, Branford, CT, United States |
| Recall initiated | 2018-03-21 |
| Classified | 2018-05-18 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2019-04-09 |
| Distributed | 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, WI |
| Countries outside the US | CA |
| Reason classes | microbial contamination |
| Lot numbers | EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181228P, EX20190103P, EX20190105P |
| Model numbers | EP-6 |
Product
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Reason for recall
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1898-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.