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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 3 of 10

Device	Model / Reference	Registries	Class	Status
Nipro Disposable Syringe	JD+10L	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2516-NIJ	FDA UDI	Class II	Active
Nipro Syringe	JD+05S	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+1938	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+64080	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35180SR	FDA UDI	Class II	Active
Nipro Syringe	JD+20L	FDA UDI	Class II	Active
Nipro Blood Collection Needle	NM+22G38	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+92045	FDA UDI	Class II	Unknown
Nipro Blood Collection Needle	NM+20G38	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2125-WEI	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+152530BC	FDA UDI	Class II	Active
Nipro Blood Collection Needle	NM+21G25	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2525	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2325	FDA UDI	Class II	Active
Nipro Syringe	JD+01T2516-NIJ	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF2419PET	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF2232PWET	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+63080	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2219	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38180SR	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10L2138	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	17GX1-1/4" HC-30W	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+102045	FDA UDI	Class II	Unknown
Nipro Hypodermic Needle	AH+1838	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2138	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+152540BC	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2525	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2225	FDA UDI	Class II	Active
Nipro Luer Adapter	LM+20G	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2025	FDA UDI	Class II	Active
NIPRO SafeTouch™ Safety Scalp Vein Set	SPR+25G19	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+72080	FDA UDI	Class II	Active
Nipro Elisio™ -m Hemodialyzer	ELISIO™-19M	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2025	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+25G19	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+104045	FDA UDI	Class II	Unknown
Nipro Blood Collection Needle	NM+20G25	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF1850PET	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+32260SR	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	16GX1-1/4" HC-30W	FDA UDI	Class II	Active
Slimline™ Blood Tubing Set With Transducer Protectors And Priming Set	BL+A226Y/V813-NIJ	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Gamma Safety Fistula Needle	17GX1-1/4	FDA UDI	Class II	Active
Nipro Syringe	JD+03S-NIJ	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2338-WEI	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+62080	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+153230BCR	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+58080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+42080	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+01T2609-WEI	FDA UDI	Class II	Active

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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