Biosyn SM-5679GRecalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10884521033115), received between Oct 4, 2017 and Jun 22, 2026 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (43 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Break

  ACCORDING TO THE REPORTER, IN AN OPEN THORACOTOMY, DURING CLOSING, THE NEEDLE BROKE WHILE SUTURING. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578459 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A WOUND CLOSURE PROCEDURE, THREE CONSECUTIVE SUTURES DID NOT BREAK INTO MULTIPLE PIECES, THE THREAD JUST CAME AWAY FROM THE BASE OF THE NEEDLE. THE DEVICES WERE TAKEN OUT OF CIRCULATION AND A DIFFERENT BATCH NUMBER OF THE SAME SUTURE WAS USED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980016 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A WOUND CLOSURE PROCEDURE, THREE CONSECUTIVE SUTURES DID NOT BREAK INTO MULTIPLE PIECES, THE THREAD JUST CAME AWAY FROM THE BASE OF THE NEEDLE. THE DEVICES WERE TAKEN OUT OF CIRCULATION AND A DIFFERENT BATCH NUMBER OF THE SAME SUTURE WAS USED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979948 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A WOUND CLOSURE PROCEDURE, THREE CONSECUTIVE SUTURES DID NOT BREAK INTO MULTIPLE PIECES, THE THREAD JUST CAME AWAY FROM THE BASE OF THE NEEDLE. THE DEVICES WERE TAKEN OUT OF CIRCULATION AND A DIFFERENT BATCH NUMBER OF THE SAME SUTURE WAS USED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979934 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BROKE BUT THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214955 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BROKE BUT THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214939 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883978 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED WHILE SUTURING. ANOTHER SUTURE FROM THE SAME LOT WAS USED AND ALSO BROKE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758577 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED WHILE SUTURING. ANOTHER SUTURE FROM THE SAME LOT WAS USED AND ALSO BROKE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758562 ↗
• MalfunctionDec 3, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, IT WAS REPORTED THAT THERE WAS A WOUND HEALING DISORDER AND THE SUTURE DID NOT ABSORB PROPERLY. PRESENTATION ON THE PLANNED SUTURE REMOVAL AFTER URETERAL RE-IMPLANTATION, THE PATIENT EXPERIENCED WOUND ROTATION, PAIN, WAS PERSISTENT AND UNCHANGED. SECRETION DID NOT OCCUR. IT WAS ALSO REPORTED IN THE UROLOGICAL ADMISSION FINDINGS THAT THE WOUND WAS STILL RED. DIRECTLY IN THE SUTURE PATH. CAREFUL MANIPULATION WITH FORCEPS. THE INTRACUTANEOUS SUTURE CAN BE PULLED OUT OF THE WOUND ALMOST UNDAMAGED.

  Patient problems: Impaired Healing; Pain

  MAUDE report 20831854 ↗
• MalfunctionNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POSTOPERATIVELY, AFTER THE SKIN SUTURING OF VARIOUS PATIENTS, THE PATIENT EXPERIENCED FREQUENT POSTOPERATIVE REDDENING OF THE WOUND. WITH ITCHING AND BURNING, WITHOUT MICROBIOLOGICAL EVIDENCE OF A PATHOGEN AND WITHOUT EVIDENCE OF A WOUND INFECTION, THEREFORE A FREQUENT ALLERGIC REACTION TO THE SUTURE MATERIAL WAS OBSERVED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Skin Burning Sensation

  MAUDE report 20706022 ↗
• MalfunctionNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POSTOPERATIVELY TO SKIN SUTURES, THE PATIENT EXPERIENCED FREQUENT REDDENING OF THE WOUND WITH ITCHING AND BURNING. WITHOUT MICROBIOLOGICAL EVIDENCE OF A PATHOGEN AND WITHOUT EVIDENCE OF A WOUND INFECTION. THEREFORE A FREQUENT ALLERGIC REACTION TO THE SUTURE MATERIAL WAS OBSERVED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Skin Burning Sensation

  MAUDE report 20705514 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, THE NEEDLE DETACHED WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127852 ↗
• MalfunctionAug 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER IMPLANTATION, THE THREAD OF THE TWO SUTURES SNAPPED MIDWAY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943962 ↗
• MalfunctionAug 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER IMPLANTATION, THE THREAD OF THE TWO SUTURES SNAPPED MIDWAY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943779 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. ANOTHER DEVICE WITH THE SAME LOT NUMBER WAS USED, BUT THE THREAD BROKE IN THE MIDDLE. TO RESOLVE THE ISSUE, A THIRD SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935883 ↗
• MalfunctionAug 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. ANOTHER DEVICE WITH THE SAME LOT NUMBER WAS USED, BUT THE THREAD BROKE IN THE MIDDLE. TO RESOLVE THE ISSUE, A THIRD SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935870 ↗
• MalfunctionMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A C-SECTION OPEN PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288999 ↗
• MalfunctionApr 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CAESARIAN SECTION, WHEN CLOSING THE UTERUS VIA CONTINUOUS SUTURING TECHNIQUE, BEFORE USING IT, THE ABSORBABLE SUTURE BROKE. HENCE, WHEN ALSO CLOSING THE SKIN VIA THE CONTINUOUS SUTURING TECHNIQUE, AFTER THE FIRST THROW, THE 3-0 ABSORBABLE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031935 ↗
• MalfunctionMar 1, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, ON THE SKIN CLOSURE, THE THREAD BROKE. THE OLD SUTURE WAS REMOVED THEN REPLACED BY A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18821127 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, THREE SUTURES SNAPPED WHILE TYING THE KNOTS. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798436 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, THREE SUTURES SNAPPED WHILE TYING THE KNOTS. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798430 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, THREE SUTURES SNAPPED WHILE TYING THE KNOTS. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798425 ↗
• MalfunctionFeb 1, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN ASSEMBLED IN THE NEEDLE HOLDER, THE TWO SUTURE THREADS BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18628755 ↗
• MalfunctionFeb 1, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN ASSEMBLED IN THE NEEDLE HOLDER, THE TWO SUTURE THREADS BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18628749 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.