Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Madison Polymeric Engineering with 11 device recalls and 2 510(k) clearances. The most recent is a device recall dated May 8, 2019: First Step Draco Pad, Product Number EP-4D.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 8, 2019 | First Step Draco Pad, Product Number EP-4DClass II · This product has been contaminated with Stenotrophomonas lactiubi. | Device recalls |
| May 8, 2019 | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305ZClass II · This product has been contaminated with Stenotrophomonas lactiubi. | Device recalls |
| Dec 14, 2018 | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydraseClass II · The product is contaminated with Pseudomonas. | Device recalls |
| Mar 21, 2018 | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3Class II · The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Device recalls |
| Mar 21, 2018 | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(WClass II · The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Device recalls |
| Mar 21, 2018 | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4Class II · The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Device recalls |
| Mar 21, 2018 | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6Class II · The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Device recalls |
| Mar 21, 2018 | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4BClass II · The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | Device recalls |
| May 6, 1997 | CYGNUS INSTRUMENT PROTECTORSK964256 · FRG | 510(k) clearances |
| Feb 14, 1997 | CYGNUS ELECTROSURGICAL TIP CLEANERK965086 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
