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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000132332
DUNS Number: —

Catalogue (464)

Page 4 of 10

Device	Model / Reference	Registries	Class	Status
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+73080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2038-NIJ	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38150AS	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2219-NIJ	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2225	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+56045	FDA UDI	Class II	Unknown
NIPRO AQUALiner™	ALS+35150AS	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A214Y/V805	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+162530BCR	FDA UDI	Class II	Active
SafeTouch™ PSV Winged Infusion Set	85951041	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+32150AR	FDA UDI	Class II	Active
Nipro Insulin Syringe	JD+01U3008-SB	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+102080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+103080	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF2032PET	FDA UDI	Class II	Active
Nipro Disposable Dose-Saver Syringe	JD+01D2238	FDA UDI	Class II	Active
Nipro Syringe	JD+01T2609-NIJ	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2025-NIJ	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	BL+A223D/V809D-NIJ	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38180AS	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35150SR	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+27G19	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+01T-WEI	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+1825	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	15GX1-1/4" HC-30W-D-CAP	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF2425PWET	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+102080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2238	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+56080	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+2032	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+1650	FDA UDI	Class II	Active
Nipro Elisio™ -m Hemodialyzer	ELISIO™-11M	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+82045	FDA UDI	Class II	Unknown
Nipro Safetouch Iv Catheter	NI-CSF2225PWET	FDA UDI	Class II	Active
Nipro Insulin Syringe	JD+01U3013-SB	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2225-NIJ	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+01T2516-WEI	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF2419PWET	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+46080	FDA UDI	Class II	Unknown
NIPRO Cellentia™-H Hemodialyzer	Cellentia™-15H	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2713	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+74045	FDA UDI	Class II	Unknown
Nipro Disposable Syringe	JD+03L2238-WEI	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38180AR	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+52045	FDA UDI	Class II	Unknown
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+53080	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2038	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	15GX1" HC-30R/C-30B TWIN PACK	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+52080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+01T	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