Dermalon 88861741-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521070721), received between Jan 24, 2018 and Jun 8, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

9 other recalls cover devices cleared under the same FDA submission (K981582); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONNECTION OF THE NEEDLE AND THREAD BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436438 ↗
• MalfunctionNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, WHILE SUTURING, THERE WAS A NEEDLE DETACHMENT. IT WAS NOTED THAT NO COMPONENT FELL IN THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773121 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422501 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422469 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422468 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD SUDDENLY BROKE.

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

  MAUDE report 18422314 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD SUDDENLY BROKE.

  Patient problems: Insufficient Information

  MAUDE report 18422282 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419630 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418902 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418897 ↗
• MalfunctionDec 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE TIME OF SKIN CLOSURE, HALFWAY THROUGH THE STITCHING, THE THREAD SUDDENLY BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401466 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS NO PROBLEM WITH THE FIRST STITCH OF THE DEVICE. WHILE TRYING TO APPLY THE SECOND STITCH WITH THE NEEDLE CUTTING INTO MUSCLE LAYER, THE NEEDLE DETACHED FROM THE THREAD. THE NEEDLE COULD NOT BE SEEN AROUND THE WOUND, IN THE STERILE FIELD, PATIENT'S CLOTHES, STRETCHER, NOR ON THE FLOOR. THE SUTURE WAS STOPPED AT ONCE.

  Patient problems: Insufficient Information

  MAUDE report 17941382 ↗
• MalfunctionMay 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE, THE NEEDLE DETACHED AWAY FROM THE SUTURE. ANOTHER SUTURE WITH DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10053515 ↗
• MalfunctionJan 24, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A SKIN SUTURE PROCEDURE, WHILE STITCHING THE SKIN TO CLOSE THE WOUND, THE DEVICE¿S THREAD BROKE AS THE PHYSICIAN SUTURED AND CLOSED THE SOFT TISSUE AT THE LATTER STAGE OF THE SURGERY. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE OPERATION. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981582. One submission often covers many models, so check the product and lot details in each record.

• Z-2920-2026 · Jun 24, 2026 · Open, Classified
  Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
• Z-0844-2024 · Dec 21, 2023 · Open, Classified
  Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK
• Z-1172-2023 · Dec 2, 2022 · Open, Classified
  Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11
• Z-1178-2023 · Dec 2, 2022 · Open, Classified
  Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41
• Z-2822-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Material 8886196262 Surgilon is intended for use in general soft tissue approximation and/or
• Z-2820-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Material 8886191022 Surgilon is intended for use in general soft tissue approximation and
• Z-2824-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Material 8886195332J Surgilon is intended for use in general soft tissue approximation and/or
• Z-2821-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886193662 Surgilon is intended for use in general soft tissue approximation and/or ligation
• Z-2823-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or l