Polysorb L-1897KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521046368), received between May 11, 2023 and Jan 15, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT DURING A BLEPHAROPLASTY PROCEDURE, THE DISTAL TIP OF THE NEEDLE BROKE OFF WHILE SUTURING AND FELL INTO THE PATIENT CAVITY. THE BROKEN NEEDLE TIP WAS RETRIEVED USING THE LEFTOVER PART OF THE NEEDLE AND A NEEDLE DRIVER. A 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 24079214 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING THE NEEDLE BROKE AND FELL INTO THE CAVITY OF THE PATIENT AND IT WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616225 ↗
• MalfunctionJun 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581752 ↗
• InjuryDec 1, 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 A LAPAROSCOPIC SCROTAL HYPOSPADIAS REPAIR RM OPERATION, DURING THE FIRST SESSION, WHILE THE GRAFT TISSUE WAS BEING SUTURED TO THE VENTRAL PART OF THE PENIS WITH A 7-0 ABSORBABLE SUTURE, IT WAS NOTICED THAT 2/3 OF THE NEEDLE TIP WAS BROKEN. AN X-RAY WAS PERFORMED TO SEARCH FOR THE BROKEN NEEDLE. HOWEVER, NO BROKEN NEEDLE TIP WAS FOUND ON THE PATIENT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. ANOTHER SUTURE WITH THE SAME LOT NUMBER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18248403 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, FIVE DAYS AFTER THE LASER CATARACT SURGERY, THE PATIENT DEVELOPED ABSCESS ON THE EYE. THE PATIENT EXPERIENCED UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE AS A RESULT. THE SURGEON HAD TO REDO THE SUTURE AFTER ABSCESS REDUCTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17148904 ↗
• MalfunctionMay 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VITRECTOMY PROCEDURE, AT THE PART OF THE EYE, THE SURGEON EXPERIENCED A BROKEN NEEDLE WHILE SUTURING. THE SURGEON REMOVED THE BROKEN PIECE FROM THE TISSUE IN ONE PIECE, AND THERE WERE NO REMAINING FRAGMENTS IN THE EYE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916320 ↗

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