The Recall Desk
HighFDA (Devices)·Z-3058-2024·Announced 2024-09-18

Medline Biopsy Tray Convenience Kits Recalled for Syringe Leaks and Breakage

Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for syringes with identified leaks and breakage that may pose patient health risks. No reported illnesses or injuries. Scored as High per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits labeled as BIOPSY TRAY-LF (Pack Number DYNDH1229, Lot Number 22FBA002) due to quality issues identified in the plastic syringes contained within these kits.

The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality defects have been identified that may pose a risk to patient health. The affected kits have been distributed worldwide.

The recalled product

Product
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Biopsy Kit
Hazard
  • leak
  • breakage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • DYNDH1229
  • Lot Number 22FBA002

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category