PDS PDP6261HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031207400), received between Jan 10, 2023 and Aug 13, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239418 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239315 ↗
• MalfunctionApr 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN TAKE OUT THE NEEDLE/SUTURE AFTER OPENING THE PACKAGE. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904883 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WERE USED. THE NEEDLE TIP BROKE ALMOST IMMEDIATELY AFTER STARTING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582945 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS EASY TO DETACH WHILE USING. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441885 ↗
• MalfunctionJan 22, 2026Break; Material Separation

  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, DURING SUTURING, AFTER ONE SIDE OF THE DOUBLE-ARMED SUTURE WAS DROPPED, THE SUTURE DETACHED FROM THE NEEDLE WHEN IT PASSED THROUGH THE SKIN. THIS ISSUE OCCURRED TWICE IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144115 ↗
• MalfunctionJan 22, 2026Break; Material Separation

  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, DURING SUTURING, AFTER ONE SIDE OF THE DOUBLE-ARMED SUTURE WAS DROPPED, THE SUTURE DETACHED FROM THE NEEDLE WHEN IT PASSED THROUGH THE SKIN. THIS ISSUE OCCURRED TWICE IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144108 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AT THE TIME OF LIGATION WITH INSTRUMENT TIE, THE SURGEON PULLED THE SUTURE AS USUAL AND IT BROKE. THE SUTURE METHOD WAS INTERRUPTED SUTURE AND THE PRODUCT WAS USED ON DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132349 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037. One submission often covers many models, so check the product and lot details in each record.

• Z-2147-2024 · May 10, 2024 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in oph
• Z-1571-2023 · Mar 31, 2023 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatri
• Z-1135-2019 · Mar 12, 2019 · Terminated
  VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SU
• Z-2533-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
• Z-2532-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
• Z-1340-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
• Z-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
• Z-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
• Z-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.