PDS Z126HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031060203), received between Jan 31, 2018 and May 15, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

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.

• MalfunctionMay 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION, THE NEEDLE AND THREAD WERE SEPARATED WHEN THE THREAD WAS REMOVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187505 ↗
• MalfunctionDec 10, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THE CLINIC IT IS REPORTED THAT DURING SURGICAL PROCEDURES THE NEEDLE OF THE SUTURE IS BROKEN. IT IS SUSPECTED THAT THE PRODUCT IS NOT AUTHENTIC FROM J&J. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769404 ↗
• MalfunctionDec 10, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THE CLINIC IT IS REPORTED THAT DURING SURGICAL PROCEDURES THE NEEDLE OF THE SUTURE IS BROKEN. IT IS SUSPECTED THAT THE PRODUCT IS NOT AUTHENTIC FROM J&J. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769397 ↗
• MalfunctionDec 10, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THE CLINIC IT IS REPORTED THAT DURING SURGICAL PROCEDURES THE NEEDLE OF THE SUTURE IS BROKEN. IT IS SUSPECTED THAT THE PRODUCT IS NOT AUTHENTIC FROM J&J. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768309 ↗
• MalfunctionDec 10, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THE CLINIC IT IS REPORTED THAT DURING SURGICAL PROCEDURES, THE NEEDLE OF THE SUTURE IS BROKEN. IT IS SUSPECTED THAT THE PRODUCT IS NOT AUTHENTIC FROM J&J. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768305 ↗
• MalfunctionMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WHEN WANTING TO USE THE SUTURES, THE UNION BETWEEN THE NEEDLE AND THE STRAND (NEEDLE ANCHOR) WAS BROKEN. THIS HAPPENED IN 3 SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044036 ↗
• MalfunctionMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WHEN WANTING TO USE THE SUTURES, THE UNION BETWEEN THE NEEDLE AND THE STRAND (NEEDLE ANCHOR) WAS BROKEN. THIS HAPPENED IN 3 SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044020 ↗
• MalfunctionMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WHEN WANTING TO USE THE SUTURES, THE UNION BETWEEN THE NEEDLE AND THE STRAND (NEEDLE ANCHOR) WAS BROKEN. THIS HAPPENED IN 3 SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044016 ↗
• MalfunctionMay 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE QR CODE OF THE SUTURE DOES NOT WORK. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039189 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IOSLATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035877 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SUTURING PROCESS, THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253131 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019808 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019797 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057783 ↗
• MalfunctionJan 31, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR CHOLEDOCHOLITH AND STENOSIS OF THE COMMON BILE DUCT AND SUTURE WAS USED. DURING THE SURGERY, THE COMMON BILE DUCT EXCEPT FOR THE STENOSED PART WAS RESECTED ON THE SIDE OF THE LIVER. THEN, THE BILE DUCT AND DUODENUM WERE ANASTOMOSED. DURING THE ANASTOMOSIS, THE SURGEON HELD THE NEEDLE TIP AFTER PLACING A FEW STITCHES. AT THAT TIME, THE NEEDLE DETACHED FROM THE SUTURE. IT IS SUPPOSED THAT THE NEEDLE TIP BROKE WHEN THE SUTURE WAS DETACHED FROM THE NEEDLE. WHEN THE NEEDLE WAS RETRIEVED, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN OFF. THE BROKEN PIECE OF THE NEEDLE TIP HAS NOT BEEN RETRIEVED YET. DURING THE OPERATION, X-RAYS WERE TAKEN BUT THE BROKEN PIECE OF THE NEEDLE TIP WAS NOT OBSERVED. THUS, THE SURGEON JUDGED THAT THE BROKEN PIECE WAS NOT RETAINED IN THE PATIENT¿S BODY. THE SURGEON OPINES THAT THE NEEDLE TIP WAS BROKEN BECAUSE HE/SHE HELD THE NEEDLE AT ITS TIP. THE SURGEON JUDGED THE BROKEN PIECE OF THE NEEDLE TIP WAS NOT RETAINED IN THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO ADDITIONAL TREATMENT SCHEDULED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232893 ↗