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NIPRO MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 3150 NW 107TH AVE, Doral, FL, 33172
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EUDAMED SRN: —
FDA FEI Number: 1000132332
DUNS Number: —

Catalogue (464)

Page 10 of 10

Device	Model / Reference	Registries	Class	Status
Surdial DX Hemodialysis System	K182940	FDA 510(k)	Class II	Active
Nipro Safe Touch Huber Infusion Set	K113470	FDA 510(k)	Class II	Active
Nipro Safetouch Locktail Safety Fistula Needle	K093985	FDA 510(k)	Class II	Active
Elisio™-H	K260533	FDA 510(k)	Class II	Active
Nipro Blood Tubing Set With Transducer Protector And Priming Set	K112628	FDA 510(k)	Class II	Active
Nipro Hypodermic Needle	K013293	FDA 510(k)	Class II	Active
Elisio-H And Elisio-M Hemodialyzers	K122347	FDA 510(k)	Class II	Active
Nipro SafeTouch IV Catheter	K161681	FDA 510(k)	Class II	Active
Safetouch Psv Winged Infusion Set With/Without Filter	K132153	FDA 510(k)	Class II	Active
Nipro Blood Tubing Set For Hemodialysis With Transducer Protectors And Priming Set	K001465	FDA 510(k)	Class II	Active
FB-U Hemodialyzer	K160444	FDA 510(k)	Class II	Active
Nipro Disposable Solution Infusion Set	K970076	FDA 510(k)	Class II	Active
Nipro Disposable Syringe With Or Without Needle	K051574	FDA 510(k)	Class II	Active
Nipro Blood Tubing Set With Transducer And Solution Set For Hemodialysis	K972206	FDA 510(k)	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