First Step Draco Pad — Class II medical device recall Z-1925-2019
Terminated recall by Madison Polymeric Engineering, reported 2019-07-10, distributed in AZ, CA, FL, IA, IL, IN, MA, MD…. This product has been contaminated with Stenotrophomonas lactiubi.
| Recall number | Z-1925-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Madison Polymeric Engineering, Branford, CT, United States |
| Recall initiated | 2019-05-08 |
| Classified | 2019-07-02 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-07-06 |
| Distributed | AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA |
| Quantity | 10,570 |
| Lot numbers | EX20191221X, EX20191226X, EX20191227X, EX20191228X |
Product
First Step Draco Pad, Product Number EP-4D
Reason for recall
This product has been contaminated with Stenotrophomonas lactiubi.
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-1925-2019. 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.