Surgical Film
FDA adverse event reports and recall history for surgical film (product code OOD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,191
- Deaths
- 7
- Injuries
- 1,122
- Malfunctions
- 61
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
- TerminatedProcess design
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Endotoxin values from testing of retains slightly exceeded the established specification.
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