NIPRO CORPORATION
7 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (7)
Registered facilities (8)
- Nipro (Thailand) Corporation Limited FEI 3002974635 · TH
- NIPRO MEDICAL CORPORATION FEI 1000132332 · FL
- NIPRO CORPORATION FEI 3000247873 · JP
- NIPRO CORPORATION ODATE FACTORY FEI 3002807710 · JP
- NIPRO MEDICAL INDUSTRIES LTD. FEI 3002807725 · JP
- SHIBUYA CORPORATION FEI 3016250252 · JP
- PT. Nipro Indonesia Jaya FEI 3010377171 · ID
- NIPRO (SHANGHAI) CO., LTD. FEI 3004138517 · CN
Recalls & enforcement
- Class IIOngoing2025-10-27Screw may loosen or fallout of Hemodialysis system
- Class IITerminated2017-12-19There is a possibility of the heparin line is occluded.
- Class IITerminated2015-08-13Some 1 1/4" needles were packaged and labeled in the 1" blister package.
- Class IITerminated2015-03-30Blood foaming was found during evaluation of the product.
- Class IIITerminated2014-04-01Device has the potential to have torn wings.
- Class IITerminated2013-05-04There 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.
- Class IITerminated2012-07-27Nipro 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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “NIPRO CORPORATION — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8030375-nipro-corporation/
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