Dialyzer, Capillary, Hollow Fiber
FDA adverse event reports and recall history for dialyzer, capillary, hollow fiber (product code FJI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 8,409
- Deaths
- 157
- Injuries
- 3,166
- Malfunctions
- 4,638
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-03Open, ClassifiedDevice Design
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
- 2016-04-05TerminatedProcess control
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Dialyzer header leak due to possible improper torque
- 2006-11-14TerminatedOther
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
- 2004-01-14TerminatedOther
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
Potential loose header (end cap) on hollow fiber dialyzers.
- 2004-01-14TerminatedOther
Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
Potential loose header (end cap) on hollow fiber dialyzers.
- 2004-01-14TerminatedOther
Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
Potential loose header (end cap) on hollow fiber dialyzers.
- 2004-01-14TerminatedOther
Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Potential loose header (end cap) on hollow fiber dialyzers.
Monitor dialyzer, capillary, hollow fiber automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.