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.

Recall Insight

This FDA Devices action (record #Z-0969-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on December 14, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Madison Polymeric Engineering is listed as the recalling firm, operating out of Branford, CT. Federal records indicate 4800 pads units are affected.

The documented reason for this recall is: The product is contaminated with Pseudomonas. Distribution data in the federal record shows the product reached: Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.