Biosyn UM-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521033351), received between Feb 13, 2018 and Dec 4, 2025 — classified as 1 injury, 30 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF A SUTURE FOR A VETERINARY CYSTOTOMY PROCEDURE ON A CHIHUAHUA, PRIOR TO THE PATIENT INCISION, THE NEEDLE DETACHED FROM THE STRAND WHILE BEING REMOVED FROM THE RETAINER. THE VETERINARIAN USED ANOTHER SUTURE STRAND WITHOUT ISSUE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715207 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A VETERINARY CESAREAN SECTION FOR A CANINE PATIENT, WHILE STARTING TO SUTURE THE UTERUS, THE SUTURE WAS TAKEN AND IMMEDIATELY DETACHED FROM THE NEEDLE. ANOTHER SUTURE FROM THE SAME LOT WAS USED BUT HAD THE SAME RESULT. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614241 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A VETERINARY CESAREAN SECTION FOR A CANINE PATIENT, WHILE STARTING TO SUTURE THE UTERUS, THE SUTURE WAS TAKEN AND IMMEDIATELY DETACHED FROM THE NEEDLE. ANOTHER SUTURE FROM THE SAME LOT WAS USED BUT HAD THE SAME RESULT. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614232 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE BUT BEFORE USING IT ON THE PATIENT, WHEN IT WAS BEING PULLED OUT FROM THE RETAINER AND PREPARING FOR SUTURING, THE NEEDLE WAS DETACHED. ANOTHER NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406726 ↗
• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING DERMAL SUTURING, THE NEEDLE DETACHED FROM THE SWAGE IN THE MIDDLE OF DOING LIGATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956603 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, THE SUTURE NEEDLE BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660097 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, THE SUTURE NEEDLE BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660087 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, THE SUTURE NEEDLE BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660049 ↗
• MalfunctionJan 24, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A VETERINARY PROCEDURE, THE SURGEON PERFORMED A FOREIGN BODY SURGERY ON THE PATIENT AND CLOSED TWO ENTEROTOMY SITES USING BIOSYN SUTURES. WITHIN A FEW HOURS OF SURGERY, THE PATIENT BECAME SEPTIC AND WAS TRANSFERRED TO ANOTHER HOSPITAL TO BE TAKEN BACK FOR SURGERY. IT WAS NOTED THAT ONE OF THE ENTEROTOMY SITES, THE SUTURE WAS COMPLETELY GONE AND THE OTHER ENTEROTOMY SITE, THE CENTRAL AREA OF THE SUTURE BROKE DOWN.

  Patient problems: Sepsis

  MAUDE report 21233316 ↗
• MalfunctionJan 24, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER DURING A VETERINARY PROCEDURE, THE SURGEON PERFORMED A FOREIGN BODY SURGERY ON THE PATIENT AND CLOSED TWO ENTEROTOMY SITES USING BIOSYN SUTURES. WITHIN A FEW HOURS OF SURGERY, THE PATIENT BECAME SEPTIC AND WAS TRANSFERRED TO ANOTHER HOSPITAL TO BE TAKEN BACK FOR SURGERY. IT WAS NOTED THAT ONE OF THE ENTEROTOMY SITES, THE SUTURE WAS COMPLETELY GONE AND THE OTHER ENTEROTOMY SITE, THE CENTRAL AREA OF THE SUTURE BROKE DOWN.

  Patient problems: Sepsis

  MAUDE report 21232449 ↗
• MalfunctionNov 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HAND INJURY SUTURING, WHEN APPLIED ON THE ARM WHILE USING CONTINUOUS SUTURING TECHNIQUE, THE THREAD OF THE TWO SUTURES WERE BROKEN. THE SUTURE WAS REPLACED WITH ANOTHER ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663220 ↗
• MalfunctionOct 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL TOTAL HYSTERECTOMY PROCEDURE, THE THREAD WAS BROKEN THEN THE NEEDLE AND THREAD GOT SE PARATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462303 ↗
• MalfunctionJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ORTHOPEDIC PROCEDURE ON A DOG, NEEDLE GOT LOOSE FROM THE STRAND. ANOTHER STRAND FROM THE SAME LOT WAS TAKEN WITH SAME ISSUE SO ANOTHER BRAND WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295321 ↗
• MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE 27 NEEDLES DETACHED. OTHER STANDS WERE TAKEN AND FINALLY THE USER TOOK ANOTHER BOX TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16286062 ↗
• MalfunctionJan 19, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MECHANICAL ILEUS SEWING GUT, THE TWO NEEDLES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203704 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE CAME OFF THE THREAD. THE ISSUE OCCURRED IN THREE OF FIVE DEVICES USED. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109422 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE CAME OFF THE THREAD. THE ISSUE OCCURRED IN THREE OF FIVE DEVICES USED. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109359 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE CAME OFF THE THREAD. THE ISSUE OCCURRED IN THREE OF FIVE DEVICES USED. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109334 ↗
• MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE FOR USAGE, THE SUTURE CAME OFF FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 15530471 ↗
• InjurySep 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE, ON STITCHING, THE NEEDLE BROKE. AN X-RAY WAS PERFORMED IN LOCATING THE NEEDLE THAT WAS RETRIEVED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12475679 ↗
• MalfunctionAug 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUTURE WAS DISCONNECTED FROM THE NEEDLE WHEN IT WAS OPENED. THE SURGERY WAS PERFORMED USING A NEW PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375679 ↗
• MalfunctionJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO SPAYING, SEROMA AND LOCAL INFLAMMATORY RESPONSE WAS OBSERVED AT SUTURE SITE. A DRAIN WAS PLACED AND WAS REPLACED 5 TIMES. DEXAMETHASONE WAS PRESCRIBED AND BAYTROL INJECTION WAS GIVEN.

  Patient problems: Inflammation; Seroma

  MAUDE report 12018906 ↗
• MalfunctionJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY IN VETERINARY CASE, THE SUTURE SITE DEVELOPED SEROMA. A DRAIN WAS PLACED AND HAD TO BE REPLACED FOR FIVE TIMES. CBC PANEL CAME BACK NORMAL, DEXAMETHASONE AND BAYTOL WERE PRESCRIBED.

  Patient problems: Seroma

  MAUDE report 12016236 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE OF SKIN ON A VETERINARY PROCEDURE, THE NEEDLE AND THREAD CAME OFF EASILY. THE SAME EVENT OCCURRED TWICE. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11825572 ↗
• MalfunctionJul 15, 2020Product Quality Problem; Unraveled Material; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER POST-OPERATIVE A SPAY PROCEDURE THE PATIENT WAS RETURNED WITH THE OMENTUM PROTRUDING THROUGH THE SKIN CLOSURE. THE SURGEON DEBRIDED THE TISSUE AND REMOVED THE SKIN SUTURES. THE SUTURE IN THE REMAINING TISSUE WAS IN SMALL CHUNKS AND WAS EXTREMELY FRIABLE BREAKING INTO SMALLER PIECES WITH TENSION, THE REMAINING SUTURE WAS THEN REMOVED. A COPIOUS LAVAGE OF THE ABDOMEN WITH WARMED, STERILE SALINE WAS THEN PERFORMED. THE LINEA WAS CLOSED IN A CONTINUOUS, PATTERN WITH A COMPETITORS DEVICE, SAME WITH THE SUBCUTANEOUS TISSUE. WHILE THE SKIN WAS CLOSED IN AN INTRADERMAL PATTERN ALSO WITH A COMPETITORS DEVICE. THE PATIENT RECEIVED INTRAOPERATIVE AMPICILLIN AND WILL GO HOME WITH POST-OPERATIVE ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10279332 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 13 more.