MEDLINE DYND20125Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196031764), received between Mar 26, 2024 and Sep 30, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 4, 2024Open, Classified

   Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).

   Z-1157-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Hematoma; Pain

  MAUDE report 50951914 ↗
• MalfunctionSep 25, 2026Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903388 ↗
• MalfunctionMar 26, 2024

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE: PACEMAKER REMOVAL. UPON OPENING THE STERILE PACKET WITH THE BULB INSIDE, THERE WAS AN UNKNOWN SUBSTANCE INSIDE THE SYRINGE. THE IMAGE LOOKS AS THOUGH IT COULD BE DRIED TAPE. SYRINGE WAS NOT USED, NO KNOWN HARM TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18977354 ↗