Chromic Gut SG-5644GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521055728), received between Sep 29, 2019 and Apr 26, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HAND SUTURING, WHILE CLOSING THE SKIN ON THE PATIENT¿S HAND USING THE SKIN CLOSURE TECHNIQUE, THE NEEDLE BROKE. MULTIPLE NEEDLES BROKE IN HALF. THE PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193521 ↗
• MalfunctionApr 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HAND SUTURING, WHILE CLOSING THE SKIN ON THE PATIENT¿S HAND USING THE SKIN CLOSURE TECHNIQUE, THE NEEDLE BROKE. MULTIPLE NEEDLES BROKE IN HALF. THE PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193448 ↗
• MalfunctionDec 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A HAND LACERATION PROCEDURE, WHILE SUTURING THE HAND OF THE PATIENT, THREE NEEDLES BROKE IN HALF. THE DOCTOR RETRIEVED ALL THE BROKEN PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321858 ↗
• MalfunctionDec 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A HAND LACERATION PROCEDURE, WHILE SUTURING THE HAND OF THE PATIENT, THREE NEEDLES BROKE IN HALF. THE DOCTOR RETRIEVED ALL THE BROKEN PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321621 ↗
• MalfunctionDec 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A HAND LACERATION PROCEDURE, WHILE SUTURING THE HAND OF THE PATIENT, THREE NEEDLES BROKE IN HALF. THE DOCTOR RETRIEVED ALL THE BROKEN PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321539 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE DOCTOR WAS SUTURING PATIENT'S HAND, THREE DIFFERENT NEEDLES BROKE IN HALF. THE DOCTOR WAS ABLE TO RETRIEVE ALL OF THE BROKEN PIECES WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171543 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE DOCTOR WAS SUTURING PATIENT'S HAND, THREE DIFFERENT NEEDLES BROKE IN HALF. THE DOCTOR WAS ABLE TO RETRIEVE ALL OF THE BROKEN PIECES WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171488 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE DOCTOR WAS SUTURING PATIENT'S HAND, THREE DIFFERENT NEEDLES BROKE IN HALF. THE DOCTOR WAS ABLE TO RETRIEVE ALL OF THE BROKEN PIECES WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171381 ↗
• MalfunctionFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN SEPTOPLASTY, WHILE USING RUNNING SUTURING TECHNIQUE, THE NEEDLE CAME OFF FROM SUTURE BEFORE IT WAS TIED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712114 ↗
• MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE SUTURING USING THE RUNNING STITCH TECHNIQUE, THREE OF THE NEEDLES FELL OF THEIR SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293593 ↗
• MalfunctionSep 29, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SEPTOPLASTY PROCEDURE, WHILE ON CLOSURE, THE SUTURE DISINTEGRATED ONCE RELEASED FROM PACKAGE WITH STRAND. ANOTHER SUTURE WAS RETRIEVED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132587 ↗

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-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)
• 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-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