Suture, Absorbable, Synthetic
FDA adverse event reports and recall history for suture, absorbable, synthetic (product code GAN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,570
- Deaths
- 8
- Injuries
- 1,983
- Malfunctions
- 3,569
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
- 2024-11-19Open, ClassifiedProcess control
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- 2024-06-14Open, ClassifiedUnder Investigation by firm
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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