Doral, FL, United States
Nipro Medical Corporation recalls
2 recalls recorded since 2018, most recently on 27 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 October 2025
- Reason
- Screw may loosen or fallout of Hemodialysis system
- Distribution
- US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0912-2026
- Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Terminated Class II Medical devices
- Recall started
- 19 December 2017
- Terminated
- 19 October 2021
- Reason
- There is a possibility of the heparin line is occluded.
- Distribution
- US Distribution to the states of : GA, NY, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1876-2018
- Nipro 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 dis
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.