Biosyn GM-181Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521032453), received between Nov 27, 2017 and Feb 23, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE SUTURE FELL OFF THE NEEDLE DURING SUTURING. A NEW SUTURE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414614 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, A NEEDLE OF A SUTURE CAME OFF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384659 ↗
• MalfunctionFeb 5, 2026Break; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE VETERINARY REPORT, DURING A PROCEDURE, THE NEEDLE CAME OFF AND THE SUTURE BROKE IN THE MIDDLE. IT WAS ALSO NOTED THAT THE NEEDLE WAS DULL. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272136 ↗
• MalfunctionFeb 5, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE VETERINARY REPORT, DURING A PROCEDURE, THE NEEDLE CAME OFF AND THE SUTURE BROKE IN THE MIDDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271850 ↗
• MalfunctionMar 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY CONTRACEPTIVE PROCEDURE, WHEN CLOSING THE WOUND, THE FIRST PACKET SN APPED WHEN THE THREAD WAS PULLED. HENCE, WHEN A SECOND PACKET WAS OPENED, THE THREAD PORTION OF THE SUTURE WAS SO TATTERED THAT IT COULD NOT BE USED IN THE FIRST PLACE. THE USAGE WAS IMMEDIATELY STOPPED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989522 ↗
• MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN TAKING OUT THE SUTURE FROM THE PACKAGING USING A CLAMP, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165006 ↗
• MalfunctionJul 10, 2023Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE DEVICE, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE NOT CONNECTED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289169 ↗
• MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVE FOR A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED, HOWEVER SAME ISSUE OCCURRED. A NEW SUTURE WITH DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824282 ↗
• MalfunctionMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, THE NEEDLE WAS CLAMPED AND AN ATTEMPT WAS MADE TO TAKEN OUT THE SUTURE, BUT THE SUTURE WAS DISCONNECTED FROM NEEDLE AND SUTURE COULD NOT BE TAKEN OUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469128 ↗
• MalfunctionJan 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARY PROCEDURE ON A DOG, THE EIGHTEEN THREADS BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 16223484 ↗
• MalfunctionNov 30, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREAD BROKE. IT WAS NOTED THAT THE DEVICE HYDROLYZED IMMEDIATELY AFTER IT WAS PREPARED AND OPENED. THE SUTURE WAS NOT USED AND A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890198 ↗
• MalfunctionOct 24, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE BUT BEFORE USING IT TO THE PATIENT, AFTER OPENING FROM THE PACKET, FIVE SUTURES WERE HYDROLYZED AND UNUSABLE. THE THREADS WERE BROKEN.

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

  MAUDE report 15660815 ↗
• MalfunctionJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE UNPACKING THE DEVICE DURING A OPEN BRAIN LESION RESECTION, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED. ANOTHER PACK WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680967 ↗
• MalfunctionApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENED, THE NEEDLE AND THE THREAD HAD ALREADY DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194454 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD CAME OFF THE NEEDLE WHILE STITCHING AT THE TIME OF WOUND CLOSURE. A NEW SUTURE WAS USED WITHOUT ISSUE.

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

  MAUDE report 13626619 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INTESTINAL TRACT ANASTOMOSIS, THE THREAD CAME OFF THE NEEDLE WHILE STITCHING AT THE TIME OF WOUND CLOSURE. A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13626555 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD CAME OFF THE NEEDLE WHILE STITCHING AT THE TIME OF WOUND CLOSURE. A NEW SUTURE WAS USED WITHOUT ISSUE.

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

  MAUDE report 13618826 ↗
• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE AND THREAD OF THE SUTURE CAME OFF DURING A VETERINARY SURGERY. A DEVICE FROM THE SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12747392 ↗
• MalfunctionAug 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE THREAD AND NEEDLE DID NOT STICK TOGETHER. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12399389 ↗
• MalfunctionJul 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE 2 NEEDLES WHEN THE PACKET WAS OPENED. A NEW PACKET WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132461 ↗
• MalfunctionJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE IN CATHETER ROOM, WHEN THE SUTURE PACKET WAS OPENED, THE NEEDLE CAME OFF. THE NEEDLE WAS DISCARDED AND ONLY THE THREAD WAS COLLECTED. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11951999 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE NEEDLE WAS HELD, THE NEEDLE AND THREAD CAME OFF IMMEDIATELY. A NEW SUTURE OF THE SAME PRODUCT ID AND LOT NUMBER WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917426 ↗
• MalfunctionMay 7, 2021Break; Break

  ACCORDING TO THE REPORTER, THREE DAYS AFTER OPEN ABDOMINAL SURGERY, THE DEVICE WAS USED FOR PERITONEAL SUTURES. WHEN THE SUTURED PART WAS CHECKED, BREAKAGE WAS FOUND IN THE THREAD. REPEAT AND ADDITIONAL SURGERY WAS PERFORMED FOR WOUND DEHISCENCE. AN UNANTICIPATED TISSUE LOSS WAS NOTED AND THERE WAS TISSUE DAMAGE. THERE WERE THREE (3) SIMILAR CASES AT THE SAME TIME, AND A TOTAL OF 4 CASES HAD THE SAME PROBLEM. ANOTHER LOT PRODUCT WAS USED, AND THERE WAS NO PROBLEM AFTER THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789564 ↗
• MalfunctionMay 7, 2021Break; Break

  ACCORDING TO THE REPORTER, THREE DAYS AFTER OPEN ABDOMINAL SURGERY, THE DEVICE WAS USED FOR PERITONEAL SUTURES. WHEN THE SUTURED PART WAS CHECKED, BREAKAGE WAS FOUND IN THE THREAD. REPEAT AND ADDITIONAL SURGERY WAS PERFORMED FOR WOUND DEHISCENCE. AN UNANTICIPATED TISSUE LOSS WAS NOTED AND THERE WAS TISSUE DAMAGE. THERE WERE THREE (3) SIMILAR CASES AT THE SAME TIME, AND A TOTAL OF 4 CASES HAD THE SAME PROBLEM. ANOTHER LOT PRODUCT WAS USED, AND THERE WAS NO PROBLEM AFTER THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789549 ↗
• MalfunctionMay 7, 2021Break; Break

  ACCORDING TO THE REPORTER, THREE DAYS AFTER OPEN ABDOMINAL SURGERY, THE DEVICE WAS USED FOR PERITONEAL SUTURES. WHEN THE SUTURED PART WAS CHECKED, BREAKAGE WAS FOUND IN THE THREAD. REPEAT AND ADDITIONAL SURGERY WAS PERFORMED FOR WOUND DEHISCENCE. AN UNANTICIPATED TISSUE LOSS WAS NOTED AND THERE WAS TISSUE DAMAGE. THERE WERE THREE (3) SIMILAR CASES AT THE SAME TIME, AND A TOTAL OF 4 CASES HAD THE SAME PROBLEM. ANOTHER LOT PRODUCT WAS USED, AND THERE WAS NO PROBLEM AFTER THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789528 ↗

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-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-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• 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-1274-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery,
• 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-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-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• 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-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - 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-1288-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, b
• 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-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-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-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

…and 13 more.