Pliers, Surgical
FDA adverse event reports and recall history for pliers, surgical (product code HTC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 409
- Deaths
- 0
- Injuries
- 15
- Malfunctions
- 387
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
- 2016-02-25Open, ClassifiedOther
Synthes Small Electric Drive (SED)
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
- 2016-02-03TerminatedNonconforming Material/Component
Synthes Small Electric Drive (SED). For use in general traumatology.
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
- 2015-01-07TerminatedDevice Design
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.
- 2009-10-26TerminatedPMA
SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
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