Biodesign G54614Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (K062729, K170016); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 7, 2024Open, Classified

   Products expire prior to the expiration date printed on the product labeling

   Z-3254-2024 · Root cause: Incorrect or no expiration date · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062729, K170016. One submission often covers many models, so check the product and lot details in each record.

• Z-3250-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
• Z-3259-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
• Z-3252-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
• Z-3260-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
• Z-3256-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
• Z-3261-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
• Z-3257-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
• Z-3253-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
• Z-3255-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
• Z-3251-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
• Z-3258-2024 · Aug 7, 2024 · Open, Classified
  Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601