PDS D8892Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031031456), received between Jan 2, 2025 and Jan 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K183183, N18331); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, 2 X BOXES OF THE SAME CODE (D8892) BLUNT POINT 1 PDS. IT WAS REPORTED THAT THE PICTURES OF THE NEEDLES ON THE BOXES (AND PACKAGING) SHOW DIFFERENT NEEDLE PICTURES ALTHOUGH BOTH ARE BLUNT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055382 ↗
• MalfunctionJan 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  2 X BOXES OF THE SAME CODE (D8892) BLUNT POINT 1 PDS. IT WAS REPORTED THAT THE PICTURES OF THE NEEDLES ON THE BOXES (AND PACKAGING) SHOW DIFFERENT NEEDLE PICTURES ALTHOUGH BOTH ARE BLUNT. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(4). DEVICE PROPERTY OF HOSPITAL, DEVICE IN POSSESSION OF NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183183, N18331. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.