Nipro Medical Corporation
Complete recall history across all FDA and CPSC categories — 11 total recalls
Nipro Medical Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Nipro Medical Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 27, 2025 | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | Screw may loosen or fallout of Hemodialysis system | Class II |
| Dec 19, 2017 | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each devi... | There is a possibility of the heparin line is occluded. | Class II |
| Aug 13, 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood... | Some 1 1/4" needles were packaged and labeled in the 1" blister package. | Class II |
| Mar 30, 2015 | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protec... | Blood foaming was found during evaluation of the product. | Class II |
| Apr 1, 2014 | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. | Device has the potential to have torn wings. | Class III |
| May 4, 2013 | NIPRO Safe Touch Safety Scalp Vein Set | There is a possibility of a crack in the CP luer connector. The position of t... | Class II |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLin... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Gui... | Class II |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner ... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Gui... | Class II |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Gui... | Class II |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hy... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Gui... | Class II |
| Jul 27, 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner... | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Gui... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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