ETHICON 774GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031010772), received between Sep 21, 2020 and Mar 31, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K946173); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BLEPH AND PTOSIS REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT SUFFERED A WOUND DEHISCENCE INFECTION POST-OP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16660522 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BLEPH AND PTOSIS REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT SUFFERED A WOUND DEHISCENCE/INFECTION POST-OP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16660458 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BLEPH AND PTOSIS REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT SUFFERED A WOUND DEHISCENCE/INFECTION POST-OP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16660454 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE AND THEY USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734838 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020 AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED CYST AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Cyst(s)

  MAUDE report 10879826 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020, AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED OPEN CONJUNCTIVAL INCISION AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10879807 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020 AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT HEALED OKAY AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879797 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020 AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED GRANULOMA FORMATION AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Granuloma

  MAUDE report 10879717 ↗
• MalfunctionOct 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. DESPITE REDOING SUTURES MULTIPLE TIMES INTRAOPERATIVELY, AND DOUBLE CHECKING BEFORE CLOSING. IT IS NOT DUE TO PROBLEMS THROWING SUTURE OR CHEESEWIRING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10687746 ↗
• MalfunctionSep 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SUTURE BECAME UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  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 cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.