McKesson SY496GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10612479214283), received between Dec 13, 2019 and Mar 18, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

28 other recalls cover devices cleared under the same FDA submission (K000037); 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SKIN CANCER EXCISION, WHILE PLACING THE BURIED INTERRUPTED SUTURES IN THE SUBCUTANEOUS LAYER, THE SUTURE WAS BREAKING WITH MINIMAL TENSION. THE SUTURE KEPT SNAPPING WHEN TRYING TO TIE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626188 ↗
• MalfunctionMar 11, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SKIN CANCER EXCISION, WHILE PLACING THE BURIED INTERRUPTED SUTURES IN THE SUBCUTANEOUS LAYER, THREE TO FOUR SUTURES WERE BREAKING WITH MINIMAL TENSION. THE SUTURES KEPT SNAPPING WHEN TRYING TO TIE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574063 ↗
• MalfunctionMar 11, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SKIN CANCER EXCISION, WHILE PLACING THE BURIED INTERRUPTED SUTURES IN THE SUBCUTANEOUS LAYER, THREE TO FOUR SUTURES WERE BREAKING WITH MINIMAL TENSION. THE SUTURES KEPT SNAPPING WHEN TRYING TO TIE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574060 ↗
• MalfunctionMar 11, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SKIN CANCER EXCISION, WHILE PLACING THE BURIED INTERRUPTED SUTURES IN THE SUBCUTANEOUS LAYER, THREE TO FOUR SUTURES WERE BREAKING WITH MINIMAL TENSION. THE SUTURES KEPT SNAPPING WHEN TRYING TO TIE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566855 ↗
• MalfunctionMar 11, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SKIN CANCER EXCISION, WHILE PLACING THE BURIED INTERRUPTED SUTURES IN THE SUBCUTANEOUS LAYER, THREE TO FOUR SUTURES WERE BREAKING WITH MINIMAL TENSION. THE SUTURES KEPT SNAPPING WHEN TRYING TO TIE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566827 ↗
• MalfunctionNov 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT RETURNED WITH SUTURE GRANULOMA AND INCOMPLETE DISSOLUTION.

  Patient problems: Granuloma

  MAUDE report 23659845 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SURGEON NOTED THAT THE SUTURES WERE PULLING OFF THE NEEDLE. IT OCCURRED ON THREE DIFFERENT ABSORBABLE SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862990 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15139393 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15139384 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135898 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135873 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135809 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135791 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135647 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15135464 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15133603 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15132795 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER A SKIN CANCER EXCISIONS PROCEDURE, THE SKIN WAS EATEN AWAY AT THE SITE OF SUTURE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Necrosis

  MAUDE report 15132508 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IT WAS NOTED THERE WERE ISSUES WITH TISSUE NECROSIS WITH THE SIX SUTURES.

  Patient problems: Necrosis; Unspecified Tissue Injury

  MAUDE report 14957706 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IT WAS NOTED THERE WERE ISSUES WITH TISSUE NECROSIS WITH THE SIX SUTURES.

  Patient problems: Necrosis; Unspecified Tissue Injury

  MAUDE report 14957675 ↗
• MalfunctionDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, THE SUTURES BROKE DURING USE.

  Patient problems: No Information

  MAUDE report 9466321 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.

• Z-1283-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1277-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• Z-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1281-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1278-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1275-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1285-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1286-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not

…and 13 more.