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Dynarex Corp.

Last updated September 17, 2026

Information

Country: US
Address: 11 Dynarex Drive, Middletown, NY, 10941
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2431014
DUNS Number: —

Catalogue (2572)

Page 52 of 52

Device	Model / Reference	Registries	Class	Status
Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove For Use With Chemotherapy Drugs	K081569	FDA 510(k)	Class I	Active
Shave Prep Tray	K855132	FDA 510(k)	Class I	Active
Dynarex Xeroform Petrolatum Dressing	K152970	FDA 510(k)	U	Active
Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414	K012816	FDA 510(k)	U	Active
Skincote	K882567	FDA 510(k)	U	Active
Dynarex Umbilical Cord Lamp, Models 6833 And 6833-B	K012917	FDA 510(k)	Class II	Active
Dynarex Non-Woven Sponge	K960388	FDA 510(k)	U	Active
Suture Removal Kit	K855131	FDA 510(k)	Class I	Active
Dynarex Drain Sponge	K991694	FDA 510(k)	Class I	Active
Dynarex Ultrasound Gel	K102637	FDA 510(k)	Class II	Active
Dynarex Enteral Delivery Pump Set With Spike (1000ml), Dynarex Enteral Feeding Sets For Gravity And Pump Use (1000ml)	K082863	FDA 510(k)	Class II	Active
Dynarex Three-Way Stopcock	K172266	FDA 510(k)	Class II	Active
Dynarex Cpr Shield With One Way Valve And Barrier Filter, Model 4921	K052743	FDA 510(k)	Class II	Active
Dynarex Non-Woven Sponge	K991695	FDA 510(k)	Class I	Active
Dynarex Eye Cups	K151575	FDA 510(k)	U	Active
Dynarex Suction Catheters & Kits	K922843	FDA 510(k)	Class I	Active
Tracheostomy Care Kit	K855130	FDA 510(k)	Class II	Active
Oral Airway	K891586	FDA 510(k)	Class I	Active
Towel Drape, Models 4409, 4410	K012957	FDA 510(k)	Class II	Active
Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large	K052314	FDA 510(k)	Class II	Active
Dynarex Tracheostomy Sponge	K983348	FDA 510(k)	U	Active
Dynarex Gauze Sponge Or Pads	K933308	FDA 510(k)	U	Active

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 8, 2018	Z-1955-2018	—	terminated	The device is equipped with a dial that has an inaccurate flow rate indicator.
Mar 3, 2016	Z-2057-2016	—	terminated	Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Jul 2, 2014	Z-2117-2014	—	terminated	"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.
May 10, 2004	Z-0951-04	—	terminated	Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
Dec 31, 2002	Z-0573-03	—	terminated	Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Dec 31, 2002	Z-0572-03	—	terminated	Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.