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Dynarex Corp.

US

Last updated September 17, 2026

Information

Country
US
Address
11 Dynarex Drive, Middletown, NY, 10941
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
2431014
DUNS Number
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Catalogue (2572)

Page 9 of 52
DeviceModel / ReferenceRegistriesClassStatus
Electrically Conductive Gel (ECG) 1239
FDA UDI
Class IIActive
Laryngeal Mask Airways 5044
FDA UDI
Class IActive
Resp-O2 Nasal Oxygen Cannula Cushion Tip 33121
FDA UDI
Class IActive
Syringes Without Needle, Non-Toxic, 1 ML, Luer Slip 6987
FDA UDI
Class IIActive
Lap Sponge, Sterile, Pre-Washed 3145
FDA UDI
Class IActive
Resp-O2 Comfort-Foam Trach Tube Holder, Anti-Disconnect, 1 PC, Adult 35026
FDA UDI
Class IActive
Resp-O2 Closed Suction Endotracheal Catheters, Sterile 31020
FDA UDI
Class IActive
Resp-O2 Intubating Stylette, 14 FR 36268
FDA UDI
Class IActive
LabChoice Microcentrifuge Tubes, Polypropylene, 5mL, Sterile 42123
FDA UDI
Class IActive
Resp-O2 Oxygen Supply Tubing 33205
FDA UDI
Class IActive
SecureSafe Syringe With Safety Needle 8915
FDA UDI
Class IIActive
Instant Cold Pack with Urea (Non-Toxic) 5"X9" 4518
FDA UDI
Class IActive
Thermometer Sheaths 5614
FDA UDI
Class IIActive
Metal Swing Rail 12950
FDA UDI
Class IActive
Durma+ Small Foam Dressing Kit, Small, 4" x 2" Foam 3123
FDA UDI
Class IIActive
Foley Catheters 4950
FDA UDI
Class IIActive
Sensi Wrap, Self-Adherent - Latex Free 6" x 5 yds Assorted Colors 3219
FDA UDI
Class IActive
Resp-O2 Nasopharyngeal Airways, 26 FR 36278
FDA UDI
Class IActive
Resp-O2 Heat Moisture Exchanger (HME) 1000 Tracheostomy Integral Oxygen Port 30300
FDA UDI
Class IActive
Resp-O2 Incentive Spirometer. Tri-Flow Chamber 36102
FDA UDI
Class IIActive
Syringes (w/o needle) 6992
FDA UDI
Class IIActive
LabChoice Microscope Slides, Frosted Yellow, Ground Corner 4175
FDA UDI
Class IActive
Cloth Surgical Tape 2" x 10 yds 3563
FDA UDI
Class IActive
Resp-O2 Oxygen Mask Medium-Concentration, Standard Pediatric 33002
FDA UDI
Class IActive
Laryngoscope Blades 4024
FDA UDI
Class IActive
DynaSafety Heavy Duty Woven Fabric Fingertip Bandages Extra Long 3769-25
FDA UDI
Class IActive
LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile 41150
FDA UDI
Class IActive
Cotton Stockinette 3694
FDA UDI
Class IActive
Gastrostomy Tube, 3 port, 16fr, ENFit 5113
FDA UDI
Class IIActive
Elongated Raised Toilet Seat without Arms 10364
FDA UDI
Class IActive
Foley Catheters 4960
FDA UDI
Class IIActive
DynaCare Toothbrushes, Teal, 46 TUFT, Soft Nylon Bristles 4862
FDA UDI
Class IActive
Sensi Wrap, Self-Adherent - Latex Free 3" x 5 yds Yellow 3338
FDA UDI
Class IActive
Resp-O2 Oxygen Supply Tubing 33200
FDA UDI
Class IActive
Syringe w/Needle 7016
FDA UDI
Class IIActive
Blood Pressure Multi-5 Cuff Kit 7098
FDA UDI
Class IIActive
SecureSafe Syringe With Safety Needle 8932
FDA UDI
Class IIActive
Resp-O2 Oxygen Regulator CGA 870 Style 36352
FDA UDI
Class IActive
Biopsy Punch, Sterile, 2.5 mm, Green 4088
FDA UDI
Class IActive
Lab Coat Knitted Cuffs & Collar Without Pockets, Medium, White 1983
FDA UDI
Class IActive
Suction Tubing w/Straw Connector 4683
FDA UDI
Class IIActive
Ever-Soft Positioning Wedge 13003
FDA UDI
Class IActive
Resp-O2 Suction Catheter Kit, 18 FR, Sterile 32056
FDA UDI
Class IActive
Sterile Gauze Pad - All Gauze 3352-25
FDA UDI
Class IActive
Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 4.0 mm 36298
FDA UDI
Class IActive
Sensi-Wrap, Self Adherent 3291
FDA UDI
Class IActive
Resp-O2 Endotracheal Tube With Stylette, Uncuffed, 4.5 mm 36232
FDA UDI
Class IIActive
IV Administration Set 7053
FDA UDI
Class IIActive
LabChoice Cell Scraper, Sterile, 25 cm 43171
FDA UDI
Class IActive
DynaRide Reclining Wheelchair 16"x16" Detach Desk Arm ELR 10238
FDA UDI
Class IActive

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Authorities

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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.

DateRecall No.ClassStatusReason
May 8, 2018Z-1955-2018—terminated

The device is equipped with a dial that has an inaccurate flow rate indicator.

Mar 3, 2016Z-2057-2016—terminated

Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.

Jul 2, 2014Z-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, 2004Z-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, 2002Z-0573-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Dec 31, 2002Z-0572-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.