Dermalon 88861749-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521070806), received between Apr 2, 2020 and Jun 14, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

8 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.

Recalls naming this device

1. Dec 2, 2022Open, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1172-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE IN HALF. THE BROKEN PIECE WAS ABLE TO BE REMOVED FROM THE SKIN OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11995902 ↗
• MalfunctionMay 26, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE TISSUE, THE NEEDLE BROKE. THE USER OPENED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885414 ↗
• MalfunctionMay 22, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING THE INCISION IN A RHINOPLASTY PROCEDURE, USING INTERRUPTED KNOT SUTURE TECHNIQUE, THE THREAD WAS BROKEN FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10084223 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SEPTORHINOPLASIC PROCEDURE, ON WOUND CLOSURE, JUST WHEN THE SURGEON THROW THE SUTURE THROUGH THE TISSUE, THE NEEDLE DETACHED FROM THE THREAD ON THE FOUR DEVICES . THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914619 ↗

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-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-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-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-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
• 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