Recall Register

Nipro Medical Corporation: FDA recalls

FDA enforcement reports name Nipro Medical Corporation as the recalling firm in 7 events. The events have 11 product records. The recalls started from 2012 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of Nipro Medical Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
27 Oct 2025Hemodialysis System, Surdial DX REF: MC+SDX01 Rx OnlyDeviceClass II1Ongoing
19 Dec 2017Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis.…DeviceClass II1Terminated
13 Aug 2015Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.DeviceClass II1Terminated
30 Mar 2015NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.DeviceClass II1Terminated
1 Apr 2014NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.DeviceClass III1Terminated
4 May 2013NIPRO Safe Touch Safety Scalp Vein SetDeviceClass II1Terminated
27 Jul 2012AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.DeviceClass II5Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Nipro Medical Corporation: events for each product type
TypeEvents
Device7
Nipro Medical Corporation: events in each class
ClassEvents
Class II6
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Nipro Medical Corporation, by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Nipro Medical Corporation: FDA recalls. https://recallregister.com/firm/nipro-medical-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
FL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Nipro Medical Corporation have?
Class II: 6 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Nipro Medical Corporation?
FDA event 97914, which the firm started on 27 Oct 2025. The first product in the record is: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
How many FDA recalls of Nipro Medical Corporation have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.