Unomedical SDN BHD
FDA adverse event reports naming Unomedical SDN BHD as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: UNOMEDICAL SDN BHD.
- Total reports
- 1,697
- Deaths
- 2
- Injuries
- 117
- Malfunctions
- 1,572
Reports per year
304
5507
608
709
210
1211
1612
35913
39514
68315
14416
317
518
219
520
Source: FDA adverse event reports by year received, 2004–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Tube, Tracheal (W/Wo Connector)BTR997
- Catheter, UrologicalKOD287
- Catheter, Retention Type, BalloonEZL256
- Tube Tracheostomy And Tube CuffJOH119
- Catheters, Suction, TracheobronchialBSY13
- Stylet, Tracheal TubeBSR11
- Catheter And Tip, SuctionJOL10
- Airway, Oropharyngeal, AnesthesiologyCAE1
- Cannula, Nasal, OxygenCAT1
- Bag, Urine Collection, Leg, For External Use, SterileFAQ1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Unomedical SDN BHD 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.