Biosyn SM-822Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10884521033269), received between Sep 19, 2018 and May 18, 2026 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BILATERAL OTOPLASTY PROCEDURE, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS ALSO REPORTED THAT WHILE BEING REMOVED FROM THE RETAINER OR WHILE PREPARING THE SUTURE PRIOR TO PATIENT INCISION, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197374 ↗
• MalfunctionMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BILATERAL OTOPLASTY PROCEDURE, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS ALSO REPORTED THAT WHILE BEING REMOVED FROM THE RETAINER OR WHILE PREPARING THE SUTURE PRIOR TO PATIENT INCISION, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197342 ↗
• MalfunctionMay 5, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25076289 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25072719 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25072642 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25072598 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25072583 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER SKIN CLOSURE, THE PATIENT HAD SKIN INFLAMMATION, REDNESS, PAIN, GRANULOMAS AND ITCHING. THE SURGEON REMOVED THE STITCHES.

  Patient problems: Granuloma; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25072514 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE AT THE BEGINNING OF USE WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, CREATING A SIGNIFICANT RISK IN RETRIEVING THE NEEDLE FROM THE SUBCUTANEOUS TISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672200 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMA RESECTION, WHILE SUTURING, THE THREAD BREAKS OFF THE NEEDLE IMMEDIATELY. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. FIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. THE ISSUE WAS RESOLVED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572496 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMA RESECTION, WHILE SUTURING, THE THREAD BREAKS OFF THE NEEDLE IMMEDIATELY. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. FIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. THE ISSUE WAS RESOLVED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572490 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMA RESECTION, WHILE SUTURING, THE THREAD BREAKS OFF THE NEEDLE IMMEDIATELY. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. FIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. THE ISSUE WAS RESOLVED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572485 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMA RESECTION, WHILE SUTURING, THE THREAD BREAKS OFF THE NEEDLE IMMEDIATELY. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. FIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. THE ISSUE WAS RESOLVED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572484 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMA RESECTION, WHILE SUTURING, THE THREAD BREAKS OFF THE NEEDLE IMMEDIATELY. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. FIVE SUTURES WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. THE ISSUE WAS RESOLVED BY USING A PRODUCT FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572472 ↗
• InjuryJun 18, 2025Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD. PUS PIMPLES DEVELOPED IN THE AREAS WHERE A SUBCUTANEOUS THREAD KNOT WAS LOCATED, AND STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, ONLY AFTER SEVERAL WEEKS.

  Patient problems: Fluid Discharge; Scar Tissue; Unspecified Infection

  MAUDE report 22283458 ↗
• MalfunctionJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD DURING NORMAL KNOTTING AT THE USUAL TENSION FOR THE TWO SUTURES. A NEW THREAD FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127528 ↗
• MalfunctionJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD DURING NORMAL KNOTTING AT THE USUAL TENSION FOR THE TWO SUTURES. A NEW THREAD FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127502 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AT THE TIME OF SUTURING ON A PLASTIC SURGERY, SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21602850 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AT THE TIME OF SUTURING ON A PLASTIC SURGERY,  SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S  SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21599389 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE TIME OF SUTURING ON A PLASTIC SURGERY, SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21599308 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AT THE TIME OF SUTURING ON A PLASTIC SURGERY , SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21599294 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE TIME OF SUTURING ON A PLASTIC SURGERY , SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21596464 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Unraveled Material; Mechanical Problem; Unraveled Material

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE BIOSYN SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY 6 WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Inflammation; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 21376260 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION, THE THREAD SEPARATED FROM THE NEEDLE WHILE SEWING THE WOUND. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305910 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21284447 ↗

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

…and 13 more.