PDS PDP463GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031048348), received between Dec 19, 2025 and Aug 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Failure to Degrade

  It was reported that a patient underwent a Plastic Surgery procedure on an unknown date and suture was used. It was reported by a sales rep that, during an unknown plastic surgery, the product (specification unknown) used on the upper mouth area (upper lip?) of a pediatric patient (age unknown) had not dissolved even after two months. This event was found before use. The sales rep explained the standard specifications regarding the absorption of PDS to the head nurse and informed her that the absorption period may vary depending on the patient. It was not a control release needle. No sample will be returned. Further details are not provided from the HP. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211720 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE COMPONENT OF BULK KIT WAS PDP463H (36 PER BOX) BEFORE, BUT IT HAS BEEN CHANGED TO PDP463G (12 PER BOX). ACCORDING TO THIS, THE QUANTITY PER KIT CHANGED FROM 6 BOXES TO 18, BUT THE OUTER LABEL STILL SHOWED THE OLD 6-BOX INDICATION ONLY. THE KIT (ESKPDP463) WAS REGISTERED WITH JJKK AND QA. THE REGISTERED MODEL NUMBER WAS DETERMINED FROM THE KIT COMPONENTS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855438 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE COMPONENT OF BLUK KIT WAS PDP463H (36 PER BOX) BEFORE, BUT IT HAS BEEN CHANGED TO PDP463G (12 PER BOX). ACCORDING TO THIS, THE QUANTITY PER KIT CHANGED FROM 6 BOXES TO 18, BUT THE OUTER LABEL STILL SHOWED THE OLD 6-BOX INDICATION ONLY. THE KIT (ESKPDP463) WAS REGISTERED WITH JJKK AND QA. THE REGISTERED MODEL NUMBER WAS DETERMINED FROM THE KIT COMPONENTS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853742 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE COMPONENT OF BLUK KIT WAS PDP463H (36 PER BOX) BEFORE, BUT IT HAS BEEN CHANGED TO PDP463G (12 PER BOX). ACCORDING TO THIS, THE QUANTITY PER KIT CHANGED FROM 6 BOXES TO 18, BUT THE OUTER LABEL STILL SHOWED THE OLD 6-BOX INDICATION ONLY. THE KIT (ESKPDP463) WAS REGISTERED WITH JJKK AND QA. THE REGISTERED MODEL NUMBER WAS DETERMINED FROM THE KIT COMPONENTS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853736 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE COMPONENT OF BLUK KIT WAS PDP463H (36 PER BOX) BEFORE, BUT IT HAS BEEN CHANGED TO PDP463G (12 PER BOX). ACCORDING TO THIS, THE QUANTITY PER KIT CHANGED FROM 6 BOXES TO 18, BUT THE OUTER LABEL STILL SHOWED THE OLD 6-BOX INDICATION ONLY. THE KIT (ESKPDP463) WAS REGISTERED WITH JJKK AND QA. THE REGISTERED MODEL NUMBER WAS DETERMINED FROM THE KIT COMPONENTS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853735 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE COMPONENT OF BLUK KIT WAS PDP463H (36 PER BOX) BEFORE, BUT IT HAS BEEN CHANGED TO PDP463G (12 PER BOX). ACCORDING TO THIS, THE QUANTITY PER KIT CHANGED FROM 6 BOXES TO 18, BUT THE OUTER LABEL STILL SHOWED THE OLD 6-BOX INDICATION ONLY. THE KIT (ESKPDP463) WAS REGISTERED WITH JJKK AND QA. THE REGISTERED MODEL NUMBER WAS DETERMINED FROM THE KIT COMPONENTS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853734 ↗