COLABEL DYNJ0365463JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489783872), received between Mar 29, 2024 and Aug 13, 2026 — classified as 4 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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. Feb 11, 2025Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

   Z-1441-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. May 18, 2023Open, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2169-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237924 ↗
• MalfunctionJun 17, 2026Dull, Blunt

  THE TUMESCENT NEEDLE WAS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536327 ↗
• MalfunctionDec 4, 2024Crack; Leak/Splash; Crack; Leak/Splash

  ACCORDING TO THE FACILITY ON (B)(6), THE MEDICAL ASSISTANT WAS FILLING UP THE 10CC SYRINGE FROM THE CFP PACK WITH LIDOCAINE AND NOTICED A LEAK FROM A LONG CRACK IN THE BODY OF THE SYRINGE AS SHE PUSHED THE AIR OUT OF THE SYRINGE. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846193 ↗
• MalfunctionMar 29, 2024Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE 20 ML SYRINGE WAS "BROKEN UPON OPENING THE PACK".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004552 ↗