The Recall Desk
HighFDA (Devices)·Z-1435-2025·Announced 2025-04-02

Medline procedure kits with plastic syringes recalled for leaks and breakage

Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide 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 recall is classified as Class II by the FDA with no reported injuries or illnesses to date. The score of 3 reflects that the product presents a potential risk of harm through leaks and breakage in medical syringes used in patient procedures, but without confirmed patient harm.

Plain-English summary

Medline Industries is recalling two models of medical procedure kits: the Bilateral Facet Tray (Pack Number DYNJRA0869A) and the Pain Management Tray-LF (Pack Number DYNJRA1749). These kits contain plastic syringes and are used in medical procedures. A total of 340 units have been identified as affected.

The recall was initiated following an FDA Safety Alert issued on March 19, 2024. The syringes in these kits have been found to have quality issues including leaks, breakage, and other defects. These issues may pose a risk to patient health during medical procedures.

The affected products were distributed worldwide, including throughout the United States and Canada. The specific lot numbers involved are 20KBD382A (for the Bilateral Facet Tray) and 24CMF477A (for the Pain Management Tray-LF).

Patients and healthcare providers who have these kits should discontinue use and contact Medline Industries for instructions on returning the products or obtaining replacements.

The recalled product

Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
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 (6)

  • 1) Pack Number DYNJRA0869A
  • 10889942531059 (each) 40889942531050 (case)
  • Lot Number 20KBD382A
  • 2) Pack Number DYNJRA1749
  • 10193489829273 (each) 40193489829274 (case)
  • Lot Number 24CMF477A

Distribution

Distributed nationwide across the United States.

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