Biosyn SM-5690Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521033153), received between Jul 12, 2017 and Dec 8, 2025 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE WAS PULLED APART FROM THE SUTURE. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT.

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

  MAUDE report 23752650 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING, THE NEEDLE WAS DETACHED. IT WAS NOTED THAT NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000054 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RADIOLOGY PROCEDURE, THE NEEDLE AND THREAD CAME OFF WHEN THE USER OPENED THE PACKAGE AND TRIED TO GRASP IT WITH A NEEDLE HOLDER WHILE PREPARING FOR SUTURING BEFORE PATIENT USE. A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796689 ↗
• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF THE NEEDLE AND THE THREAD BROKE FOR BOTH DEVICE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21432247 ↗
• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF THE NEEDLE AND THE THREAD BROKE FOR BOTH DEVICE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21432232 ↗
• InjuryFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE IN THE HEMORRHOIDS, THE NEEDLE DETACHED FROM THE FILAMENT AT THE END OF THE PROCEDURE AND REMAINED IN THE PERIANAL SOFT TISSUES. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED. AN ANASCOPY WAS DONE TO THE PATIENT TO LOCATE THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21368272 ↗
• MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST RECONSTRUCTION, WHILE SUTURING, THE NEEDLE AND THREAD DETACHED. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695620 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE THREAD DETACHED. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679047 ↗
• MalfunctionNov 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SCAR REVISION, WHILE SUTURING, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673983 ↗
• MalfunctionOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE WOUND, WHILE SUTURING, THE NEEDLE DETACHED AT THE CONNECTION WHERE THE THREAD WAS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED FOR FIVE MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484878 ↗
• MalfunctionMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NEEDLE WAS HELD IMMEDIATELY AFTER OPENING, THE NEEDLE AND THREAD GOT DETACHED. THE SAME PRODUCT FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288785 ↗
• MalfunctionDec 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN LESION REMOVAL, THE NEEDLE WAS DETACHED. THE SURGEON HAD TO TRASH THE SUTURE AND OPENED A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18270848 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN LESION REMOVAL, THE NEEDLE WAS DETACHED. THE SURGEON HAD TO TRASH THE SUTURE AND OPENED A NEW ONE AND HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124883 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN LESION REMOVAL, THE NEEDLE WAS DETACHED. THE SURGEON HAD TO TRASH THE SUTURE, OPENED A NEW ONE BUT HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123057 ↗
• MalfunctionApr 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE WAS PLACED THROUGH THE TUNICA ALBUGINEA. IT WAS ENSURED THAT THE TESTICLE WAS NOT TORSED AND TESTICLE WAS THEN BROUGHT THROUGH THE TUNNEL AND OUT THE SCROTAL INCISION. THE SUTURE WAS LOADED OVER A KEITH NEEDLE WHICH WAS THEN PASSED THROUGH THE MOST DEPENDENT PORTION OF THE SCROTUM. DURING THIS PROCESS, THE SUTURE NEEDLE POPPED OFF FROM THE SUTURE THREAD. NO DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY. ANOTHER SAME SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732171 ↗
• MalfunctionMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE WHILE THE SURGEON WAS SUTURING THE PATIENT'S RIGHT ARM. IT WAS OPENED OR REMOVED FROM THE PACKAGING A MINUTE OR TWO BEFORE THE SURGEON USED IT.

  Patient problems: Insufficient Information

  MAUDE report 16592377 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH MESH POSSIBLE AND BILATERAL ROBOTIC INGUINAL HERNIA REPAIR, WHILE THE SURGEON WAS SUTURING (THE SKIN WAS CLOSED WITH RUNNING 4.0 MONOCRYL SUTURE AND STERI-STRIPS), THE SUTURE THREAD COMPLETELY SEPARATED FROM THE SUTURE NEEDLE. THE SURGEON USED THE SAME SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404341 ↗
• MalfunctionSep 22, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EXCHANGE OF BILATERAL IMPLANTS, CAPSULECTOMY OF LEFT BREAST AND EXCISION OF FAT NECROSIS OF LEFT BREAST PROCEDURE, WHEN CLOSING OF INCISION AT THE SKIN, THE THREAD BROKE. THE SURGEON UTILIZED A SECOND SUTURE THAT BROKE AND THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462554 ↗
• MalfunctionSep 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EXCHANGE OF BILATERAL IMPLANTS, CAPSULECTOMY OF LEFT BREAST AND EXCISION OF FAT NECROSIS OF LEFT BREAST PROCEDURE, WHEN CLOSING OF INCISION AT THE SKIN, THE THREAD BROKE. THE SURGEON UTILIZED A SECOND SUTURE THAT BROKE AND THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461933 ↗
• MalfunctionJun 1, 2022Break; Break

  ACCORDING TO THE REPORTER, THREAD BROKE. 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 14569302 ↗
• InjuryMar 30, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING THE SKIN WITH SUTURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON OPENED THE INCISION AND DUG THE NEEDLE BACK OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 13950881 ↗
• MalfunctionMar 15, 2022Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SCRUB TECHNOLOGIST GRABBED AND PULLED THE SUTURE OUT OF THE PACKAGE, IT WAS NOTED THAT THERE WAS NO THREAD ATTACHED TO THE NEEDLE; AND ON THE SECOND SUTURE, THE THREAD EASILY FELL OFF THE NEEDLE WHEN PULLED OUT OF THE PACKAGE. THE SURGEON USED A COMPETITOR'S SUTURE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773029 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, AT THE TIME OF OPENING, THE 2 NEEDLES AND THREAD WERE FOUND TO BE DISENGAGED ALREADY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828047 ↗
• MalfunctionJun 24, 2021Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN REDUCTION INTERNAL FIXATION, WHILE CLOSING THE SKIN, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12059612 ↗
• MalfunctionJun 25, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE STITCHING TO CLOSE AN OPEN PROCEDURE, THE SUTURE LINE BROKE. IT WAS STATED THAT MULTIPLE PACKAGES WERE USED AS THE ISSUE OCCURRED WITH MULTIPLE PACKAGES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10196648 ↗

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-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-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-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1275-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• 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
• Z-1284-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• 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-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-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-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• 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-1282-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• 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

…and 13 more.