Mild Chromic Gut G-3810Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521054806), received between Jul 29, 2020 and Feb 3, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K142656, K885018); 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 18, 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.

• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THREE BOXES OF SUTURES POPPED OFF NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 24255031 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THREE BOXES OF SUTURES POPPED OFF NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 24255030 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THREE BOXES OF SUTURES POPPED OFF NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 24255018 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE POPPING OFF THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168598 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE POPPING OFF THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168444 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE POPPING OFF THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168418 ↗
• MalfunctionDec 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURES WERE SNAPPING OFF.

  Patient problems: Insufficient Information

  MAUDE report 11075384 ↗
• MalfunctionDec 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE PULLS OFF THE SUTURE EVERY TIME IT GETS PULLED THREW SKIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977554 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE FELL OFF ON THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10904296 ↗
• MalfunctionJul 29, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, TWO SUTURES TORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10341099 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142656, K885018. One submission often covers many models, so check the product and lot details in each record.

• Z-1388-2023 · Mar 1, 2023 · Open, Classified
  Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (G
• Z-1389-2023 · Mar 1, 2023 · Open, Classified
  Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
• Z-1390-2023 · Mar 1, 2023 · Open, Classified
  Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)