Ethicon

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.

Top device categories

• Mesh, Surgical, PolymericFTL408
• Staple, ImplantableGDW187
• Laparoscope, Gynecologic (And Accessories)HET175
• Suture, Absorbable, Synthetic, Polyglycolic AcidGAM139
• Instrument, Ultrasonic SurgicalLFL115
• Laparoscope, General & Plastic SurgeryGCJ101
• Stapler, SurgicalGAG99
• Product code KOGKOG84
• Applier, Surgical, ClipGDO63
• Device, Thermal Ablation, EndometrialMNB53

Recent recalls

• 2025-10-14Open, ClassifiedUnder Investigation by firm

  ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

  The devices were shipped unsterilized.

• 2025-09-19Open, ClassifiedUnder Investigation by firm

  STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.

  Potential for barb non-engagement.

• 2025-05-20Open, ClassifiedDevice Design

  Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

  Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

• 2025-04-03Open, ClassifiedProcess control

  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP

  Identified curing issues with the silicone during the needles manufacturing process.

• 2025-04-03Open, ClassifiedProcess control

  PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1

  Identified curing issues with the silicone during the needles manufacturing process.

• 2025-04-03Open, ClassifiedProcess control

  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

  Identified curing issues with the silicone during the needles manufacturing process.

• 2025-04-03Open, ClassifiedProcess control

  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

  Identified curing issues with the silicone during the needles manufacturing process.

• 2025-02-04Open, ClassifiedProcess control

  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

• 2025-02-04Open, ClassifiedProcess control

  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

• 2025-02-04Open, ClassifiedProcess control

  ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.