PDS Z969HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031061941), received between Dec 1, 2018 and Mar 17, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619363 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619358 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, ARE YOU AWARE OF A QUALITY DEFECT WITH ETHICON'S PDS II 2-0 Z969H SUTURES, PARTICULARLY WITH THE LOT THAT EXPIRES IN FEBRUARY 2027? WE HAVE HAD THREE RECENT CASES IN WHICH THE SUTURES BROKE. IN ONE DOG WE EVEN HAD TO RE-SUTURE THE ABDOMINAL WALL BECAUSE THE SUTURE THERE ALSO FAILED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334921 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, ARE YOU AWARE OF A QUALITY DEFECT WITH ETHICON'S PDS II 2-0 Z969H SUTURES, PARTICULARLY WITH THE LOT THAT EXPIRES IN FEBRUARY 2027? WE HAVE HAD THREE RECENT CASES IN WHICH THE SUTURES BROKE. IN ONE DOG WE EVEN HAD TO RE-SUTURE THE ABDOMINAL WALL BECAUSE THE SUTURE THERE ALSO FAILED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24334893 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, ARE YOU AWARE OF A QUALITY DEFECT WITH ETHICON'S PDS II 2-0 Z969H SUTURES, PARTICULARLY WITH THE LOT THAT EXPIRES IN FEBRUARY 2027? WE HAVE HAD THREE RECENT CASES IN WHICH THE SUTURES BROKE. IN ONE DOG WE EVEN HAD TO RE-SUTURE THE ABDOMINAL WALL BECAUSE THE SUTURE THERE ALSO FAILED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334871 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009549 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009471 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009469 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009466 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009454 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009393 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009392 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009381 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009315 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009311 ↗
• MalfunctionJan 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, ACCEPTANCE INSPECTION WAS FAILED DUE TO A FIBER WAS FOUND INSIDE THE PACKAGE DURING KIT PACK MANUFACTURING PROCESS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009226 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE SUTURE APPEARED TO BE STRETCHED AND BROKEN ON THE INSIDE OF THE ABDOMINAL WALL. THEY ARE NOT SURE IF THIS IS A PRODUCT ISSUE OR A PATIENT ISSUE. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24007825 ↗
• MalfunctionDec 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE HEALTHCARE PROFESSIONAL THAT THE NEEDLES FROM THE SUTURE WERE FALLING OFF WHEN DOING SURGERY. NO ADVERSE IMPACT PATIENT/USER. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692683 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE IS BREAKING WHILE SUTURING TO TIE OFF THE POETICAL AND THE LINIER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 25 STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144773 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SUTURING TO TIE OFF THE POETICAL AND THE LINIER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142809 ↗
• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKS WHEN THEY GO TO TIE OFF THE SUTURE. THEY ARE SEEING BLEEDING WITH SOME OF THE SUTURE BREAKS. THERE WERE NO OTHER PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13602123 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLIENT IS SAYING THAT THE STRUCTURE IS BREAKING QUITE EASILY AND NOT ITS NORMAL QUALITY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640444 ↗
• MalfunctionDec 1, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE KEPT BREAKING OFF THE NEEDLE WHILE SURGEON WAS TIGHTENING THE STITCHES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122916 ↗
• MalfunctionDec 1, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE KEPT BREAKING OFF THE NEEDLE WHILE SURGEON WAS TIGHTENING THE STITCHES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122893 ↗
• MalfunctionDec 1, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2018, AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE KEPT BREAKING OFF THE NEEDLE WHILE SURGEON WAS TIGHTENING THE STITCHES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122879 ↗