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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 2 of 10

Device	Model / Reference	Registries	Class	Status
Nipro SafeTouch TULIP Safety Fistula Needle	FT+162530BC	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+86045	FDA UDI	Class II	Unknown
Nipro Safetouch™ Ii Safety Fistula Needle	17Gx1" HTC-30R/TC-30B TWIN PACK	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+96080	FDA UDI	Class II	Unknown
Nipro Nitrile Powder Free Examination Gloves	GU-NITRIMD-PF-US2K	FDA UDI	Class I	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A223D/V809D	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+96080	FDA UDI	Class II	Active
Nipro Safetouch Iv Catheter	NI-CSF1850PWET	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10L2125	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+05L2238-WEI	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2225-NIJ	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+64045	FDA UDI	Class II	Unknown
Nipro Blood Collection Needle	NM+22G25	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2225-WEI	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	BL+A217Y/V806-NIJ	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+1632	FDA UDI	Class II	Active
Nipro Elisio™ -m Hemodialyzer	ELISIO™-21M	FDA UDI	Class II	Active
Nipro Scalp Vein Set	PR+19G19	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+106080	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+01D2516-WEI	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+32150SR	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+172530TP	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+62045	FDA UDI	Class II	Unknown
Nipro Biohole Needle With Capick Scab Remover	15GX1" HTC-30W-D-CAP	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+104080	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+162540BC	FDA UDI	Class II	Active
SafeTouch™ PSV Winged Infusion Set	85516639	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38260AS	FDA UDI	Class II	Active
Nipro Elisio™ -h Hemodialyzer	ELISIO™-11H	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	15GX1" HC-30W-D-CAP	FDA UDI	Class II	Active
Nipro Insulin Syringe	JD+01U2913-SB	FDA UDI	Class II	Active
Nipro SURDIAL DX Hemodialysis System	MC+SDX01	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	15GX1-1/4" HTC-30W-D-CAP	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set	A430/V912	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+84080	FDA UDI	Class II	Active
Nipro Elisio™ -h Hemodialyzer	ELISIO™-25H	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2538	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+42045	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2325-NIJ	FDA UDI	Class II	Active
Nipro Elisio™ -h Hemodialyzer	ELISIO™-13H	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2025	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2338	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	17GX1" HC-30R/C-30B TWIN PACK	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+142530BC	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+78080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+48080	FDA UDI	Class II	Active
Nipro Syringe	JD+10L2138	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+50ES-WEI	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+2338	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+54045	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