Polysorb GL-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521045248), received between Nov 16, 2017 and Sep 10, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017807 ↗
• InjuryFeb 8, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO OOPHORECTOMY, OMENTUM BIOPSY, AND LYSIS OF ADHESIONS, WHILE ON CLOSURE OF MIDLINE ABDOMINAL INCISION, THE NEEDLE BROKE WHILE ENGAGING IN STANDARD MANEUVER/MOVEMENT TO SECURE TISSUE WITH SUTURE. AN X-RAY WAS PERFORMED BUT THE BROKEN PIECE OF NEEDLE WAS NOT LOCATED ON X-RAY AND ON THE SURGICAL FIELD. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE AS A RESULT OF THE EVENT. SAME SUTURE FROM DIFFERENT LOT WAS USED TO COMPLETE THE CLOSURE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 16330079 ↗
• MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE OF THE TWO SUTURES DETACHED FROM THE THREAD.

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

  MAUDE report 15529353 ↗
• MalfunctionAug 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE THREAD BROKE AND THE NEEDLE POPPED OFF AFTER FIVE THROWS. THE SUTURE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15311515 ↗
• MalfunctionAug 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE THREAD BROKE AND THE NEEDLE POPPED OFF AFTER FIVE THROWS. THE SUTURE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15138675 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS COMING OFF THE SWEDGE ON SIZE 0, 3-0, AND 4-0, AND NEEDLES WERE BENDING OR BREAKING AS WELL. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103878 ↗
• MalfunctionFeb 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN ANAL FISTULOTOMY PROCEDURE, THE TIP OF THE NEEDLE BROKE WHEN IT WAS GRASPED WITH THE NEEDLE DRIVER. THE SURGEON WAS ABLE TO LOCATE THE BROKEN PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539373 ↗
• MalfunctionJun 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE MASTECTOMY PROCEDURE, WHILE CLOSING OF BREAST TISSUE, THE SUTURE BROKE WHEN CLOSING THE MIDLINE INCISION. USED A NEW SUTURE AND THE BROKEN ONE WAS CUT OUT AND THROWN AWAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 8720772 ↗
• MalfunctionApr 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN HERNIA REPAIR WITH MESH PROCEDURE, PART OF THE NEEDLE BROKE OFF INTO THE PATIENT AND NEEDLE TIP WAS RETRIEVED USING GRASPER. ANOTHER NEEDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525578 ↗
• MalfunctionMar 25, 2019Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST LUMPECTOMY, AT SUBCUTANEOUS CLOSURE, TWO STRANDS "UNRAVELED", MEANING KNOTS STARTED TO LOOSEN AFTER TYING THEM. ADDITIONAL KNOT WAS TIED ON SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448026 ↗
• MalfunctionMar 5, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE ON A MASS EXCISION, THE NEEDLE¿S TIP BROKE. THE NEEDLE WAS OUTSIDE OF THE BODY AND WAS IMMEDIATELY RETRIEVED UPON VISUAL INSPECTION. IT WAS STATED THAT THE SKIN WAS CLOSED WITHOUT INCIDENT. THE SAME SUTURE AND NEEDLE COMBINATION WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8390604 ↗
• InjuryMar 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A COLON RESECTION PROCEDURE, WHEN SUTURING TO CLOSE, THE TIP OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT CAVITY. AN X-RAY WAS USED HOWEVER THE TIP WAS NOT LOCATED AND RETRIEVED. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8386365 ↗
• MalfunctionDec 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA REPAIR, ON DERMAL CLOSURE, THE SURGEON WAS CLOSING AND THE NEEDLES POPPED OFF THE SUTURES PREMATURELY THREE TIMES IN A ROW EVEN THOUGH THE THEY WERE NOT A D-TACH NEEDLES, THEY WERE A REGULAR SWAGED ON. TO COMPLETE THE PROCEDURE, THE SURGEON KEPT ON OPENING SUTURE PACKETS UNTIL CLOSURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8195841 ↗
• MalfunctionMay 17, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIAC CATHETERIZATION, THE TIP OF THE SUTURE NEEDLE BROKE OFF INTO THE PATIENT. PIECE WAS NOTICED BY THE DOCTOR AND RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522527 ↗
• MalfunctionNov 16, 2017Difficult To Position; Difficult To Position

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTECTOMY PROCEDURE, SURGEON WAS USING A SUTURE TO SECURE ALLOGRAPH TO PATIENT AND ALSO TO CLOSE TISSUE. THE SURGEON WAS USING THE SUTURE IN A TACKING TECHNIQUE, USING INTERRUPTED SUTURES. WAS OBSERVED THE SURGEON USING A 4 THROW INSTRUMENT TIE TECHNIQUE, CREATING 2 SQUARE KNOTS FOR EACH INTERRUPTED SUTURE. AFTER TACKING 4 OR 5 AREAS OF THE MESH, THE SURGEON OBSERVED THAT SEVERAL OF THE KNOTS HAD COMPLETELY UNRAVELED AND WERE NO LONGER SECURING THE MESH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI