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 | Affected lots may have exceeded its microbial limits. |
| 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.". |
| Quantity | 285 cases |
| Distribution | US Distribution. . |
| Initiated | 2017-11-03 |
| Classified | 2018-03-26 |
| Terminated | 2018-07-17 |
| Recall number | Z-1182-2018 |
| 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-1182-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79402/
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