Plain Gut SG-5686Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521055759), received between Mar 21, 2018 and Nov 2, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

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

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

   Z-1390-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A FACE LIFT PROCEDURE, THE SUTURE DID NOT ABSORB AS EXPECTED AND CAUSED REDNESS. THE PATIENT HAD TO RETURN TO THE HOSPITAL AND NEEDED TO BE TREATED WITH ANTIBIOTICS AND SOME WERE GIVEN HYDROCORTISONE CREAM TO HELP.

  Patient problems: No Code Available; Skin Inflammation; Skin Irritation

  MAUDE report 10768620 ↗
• InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A FACE LIFT PROCEDURE, THE SUTURE DID NOT ABSORB AS EXPECTED AND CAUSED REDNESS. THE PATIENT HAD TO RETURN TO THE HOSPITAL AND NEEDED TO BE TREATED WITH ANTIBIOTICS AND SOME WERE GIVEN HYDROCORTISONE CREAM TO HELP.

  Patient problems: No Code Available; Skin Inflammation; Skin Irritation

  MAUDE report 10768615 ↗
• InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A FACE LIFT PROCEDURE, THE SUTURE DID NOT ABSORB AS EXPECTED AND CAUSED REDNESS. THE PATIENT HAD TO RETURN TO THE HOSPITAL AND NEEDED TO BE TREATED WITH ANTIBIOTICS AND SOME WERE GIVEN HYDROCORTISONE CREAM TO HELP.

  Patient problems: No Code Available; Skin Inflammation; Skin Irritation

  MAUDE report 10768613 ↗
• InjuryOct 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A FACE LIFT PROCEDURE, THE SUTURE DID NOT ABSORB AS EXPECTED THAT CAUSED REDNESS AND SWELLING WITH PUSS. THE PATIENT HAD TO RETURN TO THE HOSPITAL AND NEEDED TO BE TREATED WITH ANTIBIOTICS AND SOME WERE GIVEN HYDROCORTISONE CREAM TO HELP.

  Patient problems: No Code Available; Skin Inflammation; Skin Irritation; Swelling; Unspecified Infection

  MAUDE report 10767204 ↗
• InjuryOct 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A FACE LIFT PROCEDURE, THE SUTURE DID NOT ABSORB AS EXPECTED AND CAUSED REDNESS. THE PATIENT HAD TO RETURN TO THE HOSPITAL AND NEEDED TO BE TREATED WITH ANTIBIOTICS AND SOME WERE GIVEN HYDROCORTISONE CREAM TO HELP.

  Patient problems: No Code Available; Skin Inflammation; Skin Irritation

  MAUDE report 10767190 ↗
• MalfunctionMar 21, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE DURING SURGERY. THERE WAS NO PATIENT OUTCOME AND INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7360003 ↗

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)