Polysorb GLJ-50-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10884521045545), received between Oct 13, 2017 and Mar 30, 2026 — classified as 5 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  ACCORDING TO THE REPORTER, DURING A SURGERY FOR HYDROCEPHALUS, WHILE SUTURING THE SHUNT TUBE DURING INTRAPERITONEAL PLACEMENT, THE NEEDLE TIP BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722395 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE THREAD WAS DAMAGED AT THE CENTER. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702070 ↗
• MalfunctionMar 18, 2026Use of Device Problem

  ACCORDING TO THE REPORTER, THE LIGATED TISSUE REPORTEDLY LOOSENED AFTER BEING TIGHTLY TIED.

  Patient problems: Insufficient Information

  MAUDE report 24627226 ↗
• MalfunctionMar 18, 2026Use of Device Problem

  ACCORDING TO THE REPORTER, THE LIGATED TISSUE REPORTEDLY LOOSENED AFTER BEING TIGHTLY TIED.

  Patient problems: Insufficient Information

  MAUDE report 24627224 ↗
• InjuryMar 3, 2026Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY, IT WAS DISCOVERED THAT THE NEEDLE SUTURE WAS PASSED TO THE PHYSICIAN WITHOUT CHECKING THE TIP OF THE NEEDLE AND THE PRODUCT WAS USED IN THE BLEEDING AREA IN THE PELVIS FLOOR. WHEN THE NEEDLE WAS RETURNED TO THE INSTRUMENT NURSE, IT WAS DISCOVERED THAT THERE WAS NO TIP AND COULD NOT BE FOUND EVEN AFTER SEARCHING AROUND THE ABDOMINAL CAVITY AND THE OPERATING FIELD, AND IT COULD NOT BE FOUND EVEN AFTER X-RAY IMAGING, BUT AN OBJECT LIKE THE TIP OF THE NEEDLE WAS FOUND IN THE RELEVANT PACKET, SO THE OPERATION WAS AT THE LOWEST POSITION. THE NEEDLE THAT WAS USED ONCE WAS NOT RETURNED TO THE PACKET AND WAS STORED IN ANOTHER LOCATION, SO IT WAS BELIEVED THAT THE NEEDLE TIP WAS DAMAGED AND IT WAS USED IN THE PATIENT'S TISSUE. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY 20 MINUTES.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24501055 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHEN REMOVING SUTURE WITH SUTURE NEEDLES FROM THE PACKAGE, THE NEEDLE TIP BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192628 ↗
• MalfunctionJan 9, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026749 ↗
• MalfunctionDec 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PERITONEAL SUTURING FOR PERITONITIS, THE NEEDLE TIP BROKE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794003 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE TIP WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637625 ↗
• MalfunctionJul 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL PROCEDURE, WHILE SUTURING, THE NEEDLE TIP WAS DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609359 ↗
• MalfunctionJul 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING GASTROINTESTINAL SUTURE, THE NEEDLE TIP WAS MISSING AFTER USE. IT IS UNKNOWN WHETHER THE NEEDLE FELL INSIDE THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562321 ↗
• MalfunctionJun 4, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A PACKAGE WAS LOADED WITH NEEDLES (1 EXTRA NEEDLE) FROM THE BEGINNING. THERE WAS NO PROBLEM WITH THE THREAD ITSELF SO ALL OF IT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142996 ↗
• MalfunctionMay 26, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN INTESTINAL SUTURE DURING STOMA CREATION, THE TIP OF THE NEEDLE WAS DAMAGED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084961 ↗
• MalfunctionMar 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING COLON RESECTION, WHILE DOING ADDITIONAL SUTURING THE NEEDLE BROKE WHEN THE NEEDLE TIP WAS HELD WITH A NEEDLE HOLDER AND THE SUTURE WAS REMOVED. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21659945 ↗
• MalfunctionMar 18, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE COLON WAS RECONSTRUCTED BY FUNCTIONAL IN A COLECTOMY, SUTURE WAS USED FOR REINFORCEMENT. WHEN THE NEEDLE TIP WAS GRASPED WITH THE NEEDLE HOLDER AND THE SUTURE WAS PULLED OUT, THE NEEDLE FLEW OFF. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THE NEEDLE WAS TIP WAS DAMAGED. THE NEEDLE TIP REMAINED IN THE NEEDLE HOLDER. THE NEEDLE THAT FLEW OFF WAS COLLECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635919 ↗
• MalfunctionJan 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE NEEDLE PACK USUALLY CAME IN A PACK OF 5, BUT WHEN OPENED THERE WERE ONLY FOUR NEEDLES INSIDE THE PACKAGE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21138725 ↗
• MalfunctionJan 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL PROCEDURE, WHILE USING THE SUTURE IN THE DIGESTIVE TRACT, THE NEEDLE TIP WAS DAMAGED DURING SUTURING, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081392 ↗
• MalfunctionNov 29, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, WHILE ON THE NEEDLE COUNT, ONE NEEDLE DID NOT MATCH SO THE SURGICAL FIELD AND MAYO TABLE WERE CHECKED. WHEN CHECKING THE PACKAGE, IT LOOKED LIKE THERE WERE ONLY FOUR NEEDLE MARKS LEFT, EVEN THOUGH THERE WAS PLACE FOR FIVE.

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

  MAUDE report 20810996 ↗
• MalfunctionNov 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A DIENCEPHALIC OR INTERVENTRICULAR PITUITARY DISEASE SURGERY, DURING SUTURING NEAR THE NECK, IT WAS FOUND THAT THE NEEDLE WAS DAMAGED AT THE CENTER PART. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791001 ↗
• MalfunctionNov 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A COLON RESECTION, IT WAS FOUND THAT THERE WERE SIX NEEDLES IN THE PACKAGING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778659 ↗
• MalfunctionAug 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE PROCEDURE, THERE WERE ONLY FOUR NEEDLES IN THE PACKAGE. ONE NEEDLE WITH THE THREAD WAS MISSING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981925 ↗
• MalfunctionJul 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AT THE TIME OF SUTURING, IT WAS NOTICED THAT THE NEEDLE TIP WAS BROKEN. AFTER SEARCHING AROUND THE SURGICAL FIELD AND BED, IT WAS DISCOVERED THAT THE NEEDLE TIP HAD FALLEN ON THE SIDE OF THE ANESTHESIA MACHINE, AND THE WOUND WAS CLOSED. THE SURGICAL TIME WAS EXTENDED FOR 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818720 ↗
• MalfunctionJul 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786003 ↗
• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYSTERECTOMY, AT WOUND CLOSURE/SURGICAL INCISION CLOSURE, THE TWO NEEDLES BROKE AT THE TIP. THE NEXT ONE COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760756 ↗
• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYSTERECTOMY, AT WOUND CLOSURE/SURGICAL INCISION CLOSURE, THE TWO NEEDLES BROKE AT THE TIP. THE NEXT ONE COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760720 ↗

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