The Recall Desk
HighFDA (Devices)·Z-1464-2025·Announced 2025-04-02

Medline Procedure Kits Recalled for Syringe Quality Defects

Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units 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 involving medical devices with identified quality defects (leaks, breakage) that may pose a risk to patient health during surgical procedures. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, which meets the criteria for a High severity rating.

Plain-English summary

Medline Industries has recalled seven procedure kit products containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits include acoustic neuroma packs, angiography packs, and neuro/neuro angio packs used in neurosurgical procedures. The syringes have been identified as having leaks, breakage, and other quality issues.

These quality defects may pose a risk to patient health during procedures. The recall involves 422 units that were distributed nationwide in the US and in Canada.

Healthcare facilities and medical professionals should check their inventory against the specific lot numbers and pack numbers provided in this recall. If you have received any of these affected procedure kits, discontinue use and contact Medline Industries or the FDA. Report any adverse events or quality issues to the FDA.

The recalled product

Product
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure 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 (14)

  • 1) Pack Number DYNJ37741B: UDI/DI (each) 40193489682213 (case)
  • Lot Number 20BDB113A
  • 2) Pack Number DYNJ21519W: UDI/DI (each) 40889942255611 (case)
  • Lot Number 20BDB225A
  • 3) Pack Number DYNJ83941: UDI/DI (each) 40888277736574 (case)
  • Lot Number 22JBA879Z
  • 4) Pack Number DYNJ55678: UDI/DI (each) 40193489468688 (case)
  • Lot Number 22JBC551Z
  • 5) Pack Number DYNJ04851Q: UDI/DI (each) 40889942402176 (case)
  • Lot Number 22JBC798Z
  • 6) Pack Number DYNJ45379D: UDI/DI (each) 40195327048748 (case)
  • Lot Number 23FME560A
  • 7) Pack Number DYNJ55558C: UDI/DI (each) 40195327408214 (case)
  • Lot Number 23LMG468A

Distribution

Distributed nationwide across the United States.

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