Draco Enzymatic Deep-Cleaning Pads — Class II medical device recall Z-0969-2019
Terminated recall by Madison Polymeric Engineering, reported 2019-03-06, distributed in CA, FL, IL, IN, NJ, NY, PA, TN. The product is contaminated with Pseudomonas.
| Recall number | Z-0969-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Madison Polymeric Engineering, Branford, CT, United States |
| Recall initiated | 2018-12-14 |
| Classified | 2019-02-28 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2019-12-31 |
| Distributed | CA, FL, IL, IN, NJ, NY, PA, TN |
| Countries outside the US | CA |
| Quantity | 4,800 pads |
| Pathogens | pseudomonas |
| Lot numbers | EX20190419P, EX20190420P, EX20190423P, EX20190424P |
Product
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.
Reason for recall
The product is contaminated with Pseudomonas.
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-0969-2019. 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.