First Step Flexible Endoscope Bedside Pre-Clean Kit — Class II medical device recall Z-1182-2018
Terminated recall by Madison Polymeric Engineering, reported 2018-04-04. Affected lots may have exceeded its microbial limits.
| Recall number | Z-1182-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Madison Polymeric Engineering, Branford, CT, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-07-17 |
| Quantity | 285 cases |
| Reason classes | microbial contamination |
| Lot numbers | 209A, 80512A, EP-4D, L80520A |
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.
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-1182-2018. 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.