Surgilon 88861953-32JRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521072725), received between Dec 7, 2017 and Nov 6, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (16 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486485 ↗
• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486425 ↗
• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A DURAL CLOSURE, DURING SUTURING, THE NEEDLE WAS BROKEN ON THE CENTRAL PART, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485811 ↗
• MalfunctionApr 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR A BRAIN TUMOR RESECTION, IT WAS NOTED THAT THE NEEDLE QUANTITY IN THE PACKAGE WAS INCORRECT; THERE WERE FEWER NEEDLES IN THE PACKAGE. ANOTHER PACK WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873255 ↗
• MalfunctionJan 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CRANIOTOMY PROCEDURE, WHILE SUTURING IN THE EXTRACEREBRAL DURAL CLOSURE, THE NEEDLE TIP BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179152 ↗
• MalfunctionApr 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY, WHEN SUTURING THE DURA MATER AND USING THE NODULE AND LIGATION SUTURE TECHNIQUE, THE SURGEON NOTED THAT THE PACKAGE SHOULD HAVE HAD FIVE SUTURES, BUT IT CONTAINED SIX SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173731 ↗
• MalfunctionApr 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY, WHEN SUTURING THE DURA MATER AND USING THE NODULE AND LIGATION SUTURE TECHNIQUE, THE SURGEON NOTED THAT THE PACKAGE SHOULD HAVE HAD FIVE SUTURES, BUT IT CONTAINED SIX SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173550 ↗
• MalfunctionNov 16, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A BRAIN LAPAROTOMY, WHEN OPENING THE PACKAGE, THERE WERE SIX SUTURES FOUND INSTEAD OF JUST FIVE. THERE WERE NO PARTICULAR PROBLEMS WITH THE THREAD OR NEEDLE, SO SUTURES WERE STILL USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154270 ↗
• MalfunctionOct 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY FOR BRAIN TUMOR REMOVAL, WHEN THE SUTURE WAS PASSED THROUGH THE HOLE IN THE SKULL TO LIFT THE DURA MATER, THE NEEDLE BROKE. THE NEEDLE DID NOT HIT THE BONE NOR BROKE WHEN PULLING THE THREAD OFF THE NEEDLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026584 ↗
• MalfunctionJul 24, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE POCKET CONTAINS SIX QUANTITIES INSTEAD OF FIVE. A NEW POCKET WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385662 ↗
• MalfunctionJul 24, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CRANIOTOMY, DURING DURAL CLOSURE, AFTER UNPACKING THE SUTURE, THE SCRUB NURSE PUT THE NEEDLE TO THE NEEDLE HOLDER, THEN PASSED IT TO THE SURGEON, BUT BEFORE USE, THE NEEDLE TIP WAS CHIPPED. A TOTAL OF SIX SUTURES NEEDLES WERE CHIPPED CONTINUOUSLY. ANOTHER DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381650 ↗
• MalfunctionJan 5, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON OPENING THE PACKET BEFORE USING THE PRODUCT IT WAS SUPPOSED TO CONTAIN FIVE PIECES BUT THERE WERE SIX PIECES. ANOTHER PACKET OF THE SAME PRODUCT WAS USED TO FIX THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109286 ↗
• InjurySep 13, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SURGERY, THE NEEDLE BROKE. IT WAS UNKNOWN AT WHAT POINT THE NEEDLE BREAKAGE OCCURRED, SO AN X-RAY EXAMINATION WAS PERFORMED TO THE PATIENT AND IT CONFIRMED THAT THERE IS NO RESIDUAL MATERIAL. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15411798 ↗
• MalfunctionJun 15, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A SUBCUTANEOUS SUTURE, AFTER OPENING, SIX PIECES OF PRODUCTS WERE FOUND TO BE INCLUDED DESPITE FIVE PIECES SHOULD BE INCLUDED. THE SURGEON STOPPED USING IT AND A NEW PACKET WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14707707 ↗
• MalfunctionJun 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PLASTIC SURGERY, AT THE TIME OF SKIN SUTURE, THE SURGEON FOUND THAT THE QUANTITY OF THE DEVICE WAS ONE MORE THAN USUAL. THE SURGEON DECIDED NOT TO USED ANY SUTURE FROM THE SAME BOX. ANOTHER SUTURE FROM A DIFFERENT BATCH WAS USED INSTEAD. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14689711 ↗
• MalfunctionNov 17, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE UNPACKING THE DEVICE, THE NURSE NOTICED THAT THERE WERE 6 PACKS IN THE BOX WHEN SUPPOSEDLY IT SHOULD ONLY HAVE 5. DEVICE WAS NOT USED ON PATIENT. NEW DEVICE WAS TAKEN OUT TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10851869 ↗
• MalfunctionMar 19, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE SIX PIECES OF NEEDLE AND THREAD, IN SPITE OF FIVE PIECES IN USUAL. THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9857329 ↗
• MalfunctionJul 30, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, A NURSE FOUND THAT ONLY 4 SUTURES IN A SINGLE PACKET IN WHICH SHOULD HAVE CONTAINED 5 SUTURES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8841125 ↗
• InjuryApr 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY, NEEDLE BREAKAGE OCCURRED WHEN THE DOCTOR GRIPPED THE NEEDLE TIP. X-RAY WAS ALSO PERFORMED, AND NOTHING REMAINED IN THE PATIENT CAVITY. THE PART FELL INTO THE PATIENT'S CAVITY AND COULD NOT BE RETRIEVED. LESS THAN 200 CC OF BLEEDING OCCURRED AND SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 8556116 ↗
• MalfunctionMay 22, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A CRANIOTOMY PROCEDURE, 6 PRODUCTS WERE FOUND IN A 5-PRODUCTS PACKAGE BY THE NURSE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533046 ↗
• MalfunctionMay 21, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A CRANIOTOMY SURGERY, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529775 ↗
• MalfunctionMar 30, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, THERE WERE TOO MANY DEVICES IN THE PACKAGE. THERE WERE 6 IN A 5 DEVICE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7386282 ↗
• MalfunctionFeb 28, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304547 ↗
• MalfunctionFeb 27, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE BROKE. THE PATIENT STATUS WAS REPORTED NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7300807 ↗
• MalfunctionFeb 15, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE WHEN OPENING THE PACKAGE, IT WAS CONFIRMED THAT THERE WERE 6 NEEDLES PRESENT IN THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PROCEDURE. THIS ISSUE WAS NOTICED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273339 ↗

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-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-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-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-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