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NIPRO MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 3150 NW 107TH AVE, Doral, FL, 33172
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000132332
DUNS Number: —

Catalogue (464)

Page 6 of 10

Device	Model / Reference	Registries	Class	Status
Nipro Solution Infusion Set	IS-01-A/A-21G/NV	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+05L2125-WEI	FDA UDI	Class II	Active
Nipro Latex Examination Gloves	GU-SMALL-PF-1KUS	FDA UDI	Class I	Active
Nipro Syringe	JD+10L	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35180SS	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2516	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	17GX1" HTC-30W	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+68080	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+3013	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+05L2138-WEI	FDA UDI	Class II	Active
Nipro Solution Infusion Set	IS-01-A/A-21GS	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+1850	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	15GX1" HC-30W	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF1650PWET	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2225	FDA UDI	Class II	Active
Nipro Priming Set	PS+01	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38260SR	FDA UDI	Class II	Active
Nipro Syringe	JD+10L2225	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2516-NIJ	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38260AR	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2332-NIJ	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2516-WEI	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2038	FDA UDI	Class II	Active
Nipro Latex Examination Gloves	GU-MEDIUM-PF-1KUS	FDA UDI	Class I	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+83080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+43080	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+23G19	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10L2238	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF1650PET	FDA UDI	Class II	Active
Nipro Syringe	JD+10L2025	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+66045	FDA UDI	Class II	Unknown
Cronus HP PTA Balloon Catheter	NHP+74080	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35260SR	FDA UDI	Class II	Active
NIPRO SafeTouch™ Safety Scalp Vein Set	SPR+23G19	FDA UDI	Class II	Active
Nipro Syringe	JD+01T2713	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2238	FDA UDI	Class II	Active
Nipro Nitrile Powder Free Examination Gloves	GU-NITRIXS-PF-US2K	FDA UDI	Class I	Active
SafeTouch™ PSV Winged Infusion Set with Filter	85516620	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A209Y/V803	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+84045	FDA UDI	Class II	Unknown
Nipro Safetouch Iv Catheter	NI-CSF2050PWET	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	14GX1	FDA UDI	Class II	Active
Nipro Syringe	JD+10L2125	FDA UDI	Class II	Active
Nipro Disposable Dose-Saver Syringe	JD+03D2238	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+172530BCR	FDA UDI	Class II	Active
Nipro Syringe	JD+05L	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+2025	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF2032PWET	FDA UDI	Class II	Active
Nipro Elisio™ -h Hemodialyzer	ELISIO™-15H	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+53080	FDA UDI	Class II	Unknown

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FDA Recalls (12)

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
Oct 27, 2025	Z-0912-2026	—	open, classified	Screw may loosen or fallout of Hemodialysis system
Dec 19, 2017	Z-1876-2018	—	terminated	There is a possibility of the heparin line is occluded.
Aug 13, 2015	Z-0161-2016	—	terminated	Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Mar 30, 2015	Z-0624-2016	—	terminated	Blood foaming was found during evaluation of the product.
Apr 1, 2014	Z-0599-2016	—	terminated	Device has the potential to have torn wings.
May 4, 2013	Z-1834-2014	—	terminated	There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
Jul 27, 2012	Z-0135-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0134-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0136-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0137-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0138-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jan 13, 2010	Z-1103-2010	—	terminated	Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in