Suture, Nonabsorbable
FDA adverse event reports and recall history for suture, nonabsorbable (product code GAO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 598
- Deaths
- 10
- Injuries
- 341
- Malfunctions
- 226
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
- 2015-07-24TerminatedOther
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
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