Class II — Madison Polymeric Engineering
| Recalling firm | MADISON POLYMERIC ENGINEERING |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. |
| Product | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4 |
| Quantity | 1422 cases/99540 kits |
| Distribution | The products were distributed to the following US states: 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, and WI. The products were also distributed in Canada. |
| Initiated | 2018-03-21 |
| Classified | 2018-05-18 |
| Terminated | 2019-04-09 |
| Recall number | Z-1896-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Madison Polymeric Engineering (Z-1896-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79826/
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