Halyard Health
FDA adverse event reports naming Halyard Health as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: HALYARD HEALTH.
- Total reports
- 1,986
- Deaths
- 36
- Injuries
- 152
- Malfunctions
- 1,797
Reports per year
Source: FDA adverse event reports by year received, 2015–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Catheters, Suction, TracheobronchialBSY1,064
- Tubes, Gastrointestinal (And Accessories)KNT397
- Tube, Tracheal (W/Wo Connector)BTR179
- Tube, Gastro-EnterostomyKGC145
- Catheter And Tip, SuctionJOL71
- Wrap, SterilizationFRG18
- Pump, Infusion, ElastomericMEB16
- Probe, Radiofrequency LesionGXI15
- Applicator, Absorbent Tipped, Non-SterileKXF14
- Condenser, Heat And Moisture (Artificial Nose)BYD8
Recent recalls
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2017-11-18TerminatedUnder Investigation by firm
NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- 2016-12-14TerminatedUnder Investigation by firm
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Monitor Halyard Health 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.