Madison Polymeric Engineering

Branford, CT, US

MADISON POLYMERIC ENGINEERING appears in FDA device records in Branford, CT. FDA records list 2 510(k) clearances between 1997-02-14 and 1997-05-06, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 12 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 12
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to Madison Polymeric Engineering carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Cygnus Medical LLCregistration, enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Madison Polymeric Engineering in 1997.

Clearances by year, as a table

510(k) clearance decisions for Madison Polymeric Engineering, by decision year
Year	Clearances
1997	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K964256	CYGNUS INSTRUMENT PROTECTORS	FRG	Substantially Equivalent	1997-05-06
K965086	CYGNUS ELECTROSURGICAL TIP CLEANER	GEI	Substantially Equivalent	1997-02-14

Registered establishments

FDA registered establishments for Madison Polymeric Engineering, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3005108347	3001451466	Cygnus Medical LLC	965 W Main St, Branford, CT 06405 US	2026	CCX FRL FSM GEJ KDD LRP LYV MNL PXV
1225691	3001451466	MADISON POLYMERIC ENGINEERING	965 W. MAIN STREET, BRANFORD, CT 06405 US	2026	CCX FRL GEJ JRJ KDD KPY LRP LYV PXV

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1925-2019	First Step Draco Pad, Product Number EP-4D	This product has been contaminated with Stenotrophomonas lactiubi.	Class II	2019-05-08	Terminated
Z-1924-2019	Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z	This product has been contaminated with Stenotrophomonas lactiubi.	Class II	2019-05-08	Terminated
Z-0969-2019	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.	The product is contaminated with Pseudomonas.	Class II	2018-12-14	Terminated
Z-1900-2018	Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1899-2018	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(W)	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1898-2018	First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1897-2018	First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1896-2018	First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1895-2018	First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	2018-03-21	Terminated
Z-1182-2018	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.".	Affected lots may have exceeded its microbial limits.	Class II	2017-11-03	Terminated
Z-2211-2017	Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z	Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.	Class II	2017-04-17	Terminated
Z-1389-2016	Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).	Foreign material in container	Class III	2016-03-17	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain