The Recall Desk
HighFDA (Devices)·Z-1442-2025·Announced 2025-04-02

Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects

Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.

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: Class II recall of medical device kit. The syringe defects (leaks, breakage) in a sterile procedure kit present risk of compromised patient care. No illnesses or injuries reported, which per the severity rubric limits classification to High.

Plain-English summary

Medline Industries is recalling General Endoscopy procedure kits (Pack Number DYNJ44673G) due to plastic syringe defects. The syringes are affected by an FDA Safety Alert issued March 19, 2024, and have been identified to have leaks, breakage, and other quality issues that may pose a risk to patient health.

The affected kit has lot number 22KDC145A and has been distributed worldwide, including throughout the United States and Canada.

The recalled product

Product
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Endoscopy / Surgical Kit
Hazard
  • leaks
  • breakage
  • contamination-risk

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)

  • 1) Pack Number DYNJ44673G: UDI/DI 10195327127473 (each) 40195327127474 (case)
  • Lot Number 22KDC145A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category