Biosyn UM-986Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884523004069), received between Sep 20, 2021 and Jun 29, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break

  ACCORDING TO THE REPORTER, DURING AN OUTPATIENT EYELID AND CONJUNCTIVAL LACERATION SUTURING PROCEDURE, THE SUTURE BROKE WHILE THE FIRST STITCH WAS BEING TIGHTENED AND THE KNOT TIED. THE PHYSICIAN HAD NOT APPLIED EXCESSIVE TRACTION. AFTER ASSESSING THAT THE REMAINING SUTURE COULD STILL BE USED, THE PHYSICIAN CONTINUED THE SUTURING WITH THE SAME NEEDLE, REINSERTING IT AT THE SAME SITE. PARTICULAR ATTENTION WAS GIVEN TO THE TENSION DURING SUBSEQUENT KNOT TYING TO PREVENT FURTHER BREAKAGE WHILE ENSURING THE KNOTS WERE SECURE UNTIL THE SUTURING WAS COMPLETED. AS A RESULT, THE PROCEDURE WAS SLOWED AND REQUIRED APPROXIMATELY TWICE THE USUAL TIME. THE SURGICAL TIME WAS EXTENDED BUT NOT MORE THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 25652918 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PEDIATRIC SURGERY (LAPAROSCOPIC AND OPEN PROCEDURE), THE SUTURE EXPERIENCED NEEDLE AND THREAD DETACHMENT PRIOR TO USE. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315728 ↗
• MalfunctionDec 25, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DUPLICATE OF PE (B)(4).

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

  MAUDE report 23891839 ↗
• MalfunctionDec 15, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PREPUCE, FIVE MINUTES AFTER OPENING THE SUTURE, THE THREAD BROKE ON THE SPOT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802534 ↗
• InjuryDec 4, 2025Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED THAT DURING A PEDIATRIC UROLOGY SURGERY, THE SUTURE KNOT LOST INTEGRITY AND THE WOUND EDGES SEPARATED, RESULTING IN READMITTANCE TO THE HOSPITAL. THE SAME ISSUE OCCURRED ON OTHER SUTURE FROM THE SAME PACKAGE.

  Patient problems: Wound Dehiscence

  MAUDE report 23715935 ↗
• MalfunctionNov 19, 2025Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN SKIN SUTURING, WHILE PREPARING TO SUTURE THE SKIN, THE NEEDLE BROKE AS SOON AS IT WAS OPENED. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594996 ↗
• InjuryNov 13, 2025Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED THAT DURING A PEDIATRIC UROLOGY SURGERY, THE SUTURE KNOT LOST INTEGRITY AND THE WOUND EDGES SEPARATED, RESULTING IN READMITTANCE TO THE HOSPITAL. THE SAME ISSUE OCCURRED ON OTHER SUTURE FROM THE SAME PACKAGE.

  Patient problems: Wound Dehiscence

  MAUDE report 23541967 ↗
• MalfunctionSep 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC ARM TRAUMA, THE THREAD WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062458 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE AND SUTURE WERE DETACHED WHEN THE DOCTOR UNPACKED THE SUTURE WITH THE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010655 ↗
• InjuryJun 30, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HEMORRHOIDS TREATMENT PROCEDURE, WHILE PERFORMING A RECTAL MUCOSAL SUSPENSION SUTURE, THE SUTURING NEEDLE BROKE AND WAS LEFT IN THE PATIENT'S BODY. A MOBILE FLUOROSCOPIC X-RAY WAS OBTAINED TO LOCATE AND REMOVED THE COMPONENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14879648 ↗
• MalfunctionApr 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT COMMUNICATING HYDROCELE, WHILE SUTURING, THE POSTERIOR 1/3 OF THE NEEDLE BODY WAS BROKEN. THE BROKEN NEEDLE WAS FOUND IMMEDIATELY AND KEPT IT AFTER COMPARED ITS COMPLETENESS. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE SUTURE NEEDLE WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086683 ↗
• MalfunctionSep 20, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER THE DOCTOR OPENED THE PACKAGE, BOTH SUTURE WAS VERY BRITTLE BY GENTLY PULLING IT, AND IT BROKE WHEN BEING PULLED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497501 ↗

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-1276-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - 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-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-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
• 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-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-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
• 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-1279-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• 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-1291-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but n
• Z-1298-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• 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-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no

…and 13 more.