Surgilon 88861954-32JRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521072732), received between Nov 15, 2018 and Nov 15, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (6 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 18, 2026.

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.

• MalfunctionNov 15, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN FIXATING THE SUTURE, THE PACKAGE HAD (B)(4) UNITS, WHICH NORMALLY HAD (B)(4) UNITS. IT WAS NOTED THAT IT WAS DISCONTINUED TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695534 ↗
• MalfunctionAug 9, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY INTRACRANIAL TUMOR RESECTION PROCEDURE, A SUTURE WAS USED FOR DURA MATER CLOSURE. HOWEVER, A PROBLEM OCCURRED DUE TO A DISCREPANCY IN THE NEEDLE COUNT, RESULTING IN ONE PACKET OF SUTURES OUT OF FOUR LOTS POSSIBLY CONTAINING SIX SUTURES INSTEAD OF THE USUAL FIVE. DESPITE THIS ISSUE, THE SURGEON MANAGED TO COMPLETE THE PROCEDURE, BUT ONE EXCESS DEFECTIVE PRODUCT WAS PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494991 ↗
• MalfunctionAug 9, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY INTRACRANIAL TUMOR RESECTION PROCEDURE, A SUTURE WAS USED FOR DURA MATER CLOSURE. HOWEVER, A PROBLEM OCCURRED DUE TO A DISCREPANCY IN THE NEEDLE COUNT, RESULTING IN ONE PACKET OF SUTURES OUT OF FOUR LOTS POSSIBLY CONTAINING SIX SUTURES INSTEAD OF THE USUAL FIVE. DESPITE THIS ISSUE, THE SURGEON MANAGED TO COMPLETE THE PROCEDURE, BUT ONE EXCESS DEFECTIVE PRODUCT WAS PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493378 ↗
• MalfunctionAug 9, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY INTRACRANIAL TUMOR RESECTION PROCEDURE, A SUTURE WAS USED FOR DURA MATER CLOSURE. HOWEVER, A PROBLEM OCCURRED DUE TO A DISCREPANCY IN THE NEEDLE COUNT, RESULTING IN ONE PACKET OF SUTURES OUT OF FOUR LOTS POSSIBLY CONTAINING SIX SUTURES INSTEAD OF THE USUAL FIVE. DESPITE THIS ISSUE, THE SURGEON MANAGED TO COMPLETE THE PROCEDURE, BUT ONE EXCESS DEFECTIVE PRODUCT WAS PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492473 ↗
• MalfunctionAug 9, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY INTRACRANIAL TUMOR RESECTION PROCEDURE, A SUTURE WAS USED FOR DURA MATER CLOSURE. HOWEVER, A PROBLEM OCCURRED DUE TO A DISCREPANCY IN THE NEEDLE COUNT, RESULTING IN ONE PACKET OF SUTURES OUT OF FOUR LOTS POSSIBLY CONTAINING SIX SUTURES INSTEAD OF THE USUAL FIVE. DESPITE THIS ISSUE, THE SURGEON MANAGED TO COMPLETE THE PROCEDURE, BUT ONE EXCESS DEFECTIVE PRODUCT WAS PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492466 ↗
• MalfunctionNov 15, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY, THE PRODUCT WAS USED FOR DURA MATER SUTURE AND IT WAS THE FIRST PACKET. WHEN THE NURSE OPENED THE PACKET HE/SHE FOUND THAT THERE WERE ONLY 4 IN THE PACKET. IN ADDITION, HE/SHE POINTED OUT THAT THERE WERE ONLY 4 HOLES IN THE SPONGE INSIDE THE PACKAGE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8076531 ↗

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-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-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-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-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