The Recall Desk
HighFDA (Devices)·Z-1461-2025·Announced 2025-04-02

Medline Procedure Kits Recalled for Syringe Leaks and Breakage

Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.

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: This is an FDA Class II recall of medical syringes with confirmed quality defects (leaks and breakage) used in invasive surgical procedures. No injuries have been reported, but the defects affect risk-of-harm medical devices, meeting the High severity criterion for products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling 2,161 medical procedure kits that contain plastic syringes with quality defects. These kits are used in various surgical and medical procedures, including head and neck surgery, ENT procedures, dental procedures, and other applications.

The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. The syringes have been identified as having quality issues, including leaks and breakage, that may pose a risk to patient health.

These recalled kits have been distributed worldwide, including throughout the United States and Canada. Multiple kit types and lot numbers are included in this recall.

The recalled product

Product
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • leaks
  • breakage
  • quality-defect

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 (20)

  • 1) Pack Number DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case)
  • Lot Number 20BDA583A
  • 2) Pack Number DYNJ37741B: UDI/DI 10193489682212 (each) 40193489682213 (case)
  • Lot Number 20BDB113A
  • 3) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case)
  • Lot Number 20FBS559A
  • 4) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case)
  • Lot Number 20FMA565A
  • 5) Pack Number DYNJ37707D: UDI/DI 10193489258936 (each) 40193489258937 (case)
  • Lot Number 20HKB321A
  • 6) Pack Number DYNJ64526A: UDI/DI 10193489531589 (each) 40193489531580 (case)
  • Lot Number 20HMC644A
  • 7) Pack Number DYNJ62755B: UDI/DI 10193489296792 (each) 40193489296793 (case)
  • Lot Number 20HMD066A
  • 8) Pack Number DYNJ61634B: UDI/DI 10888277756168 (each) 40888277756169 (case)
  • Lot Number 20HMD167A
  • 9) Pack Number DYNJ83129: UDI/DI 10193489366815 (each) 40193489366816 (case)
  • Lot Number 20JKA848A
  • 10) Pack Number DYNJ35906F: UDI/DI 10193489718577 (each) 40193489718578 (case)
  • Lot Number 20LBI228Z

Distribution

Distributed nationwide across the United States.

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