Data / Medical devices / United States / Dynarex Corp.

Dynarex Corp.: FDA-registered device maker in Middletown, NY, United States, 6 510(k) clearances

Name: Dynarex Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dynarex Corp. is registered with the FDA (registration 2431014) in Middletown, NY, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 3, 2016. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2431014
Address: 11 Dynarex Drive, Middletown, NY, United States, 10941
Owner or operator: DYNAREX CORP. (2431014)
Roles: Specification developer
First device listed: December 19, 2007
Registered through: 2027
Brand names listed: 3380 - Eye Cups, Non-Sterile, 50/6/Cs, 3401 - Packing Strips Plain, Sterile, 1/4"¿ x 5 yds, 12/Cs, 3402 - Packing Strips Plain, Sterile, 1/2"¿ x 5 yds, 12/Cs, 3403 - Packing Strips Plain, Sterile, 1"¿ x 5 yds, 12/Cs, 3404 - Packing Strips Plain, Sterile, 2"¿ x 5 yds, 12/Cs, 3411 - Packing Strips Iodoform, Sterile, 1/4"¿ x 5 yds, 12/Cs, 3412 - Packing Strips Iodoform, Sterile, 1/2"¿ x 5 yds, 12/Cs, 3413 - Packing Strips Iodoform, Sterile, 1" x 5 yds, 12/Cs and more

Devices it lists

Device	Product code	Class	Role	Source
Cup, Eye	LXQ	U	Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Specification developer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Specification developer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Specification developer	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 3, 2016	K152970	Dynarex Xeroform Petrolatum Dressing	FRO	Substantially Equivalent	Dynarex Corporation	accessdata.fda.gov
September 1, 2015	K151575	Dynarex Eye Cups	LXQ	Substantially Equivalent	Dynarex Corporation	accessdata.fda.gov
January 9, 2009	K082863	DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)	KNT	Substantially Equivalent	Dynarex Corporation	accessdata.fda.gov
September 12, 2008	K081569	DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS	LZA	Substantially Equivalent	Dynarex Corporation	accessdata.fda.gov
December 22, 2005	K052743	DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921	CBP	Substantially Equivalent	Dynarex Corp.	accessdata.fda.gov
October 17, 2002	K012816	DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414	FRO	Substantially Equivalent	Dynarex Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 8, 2018	80058	Class II	Terminated	Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for m	The device is equipped with a dial that has an inaccurate flow rate indicator.	accessdata.fda.gov
March 3, 2016	73584	Class II	Terminated	dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection	Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.	accessdata.fda.gov
July 2, 2014	68681	Class II	Terminated	CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.	"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.	accessdata.fda.gov
May 10, 2004	29031	Not yet classified	Terminated	100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages pe	Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.	accessdata.fda.gov
December 31, 2002	25310	Not yet classified	Terminated	Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. Product is labeled with a Late	Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.	accessdata.fda.gov

Compare with other makers

Updated October 3, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.