The Recall Desk
HighFDA (Devices)·Z-1440-2025·Announced 2025-04-02

Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk

Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.

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 procedure kits with plastic syringe defects (leaks and breakage) that pose a potential risk to patient health. No illnesses or injuries have been reported, but the quality issues in medical devices used in invasive procedures warrant a High severity classification.

Plain-English summary

Medline Industries is recalling three types of medical procedure kits used in hospital and clinical settings. A total of 808 units have been distributed.

These kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks and breakage have been identified in the syringes, which may pose a risk to patient health during medical procedures.

The affected kits have been distributed nationwide in the United States and in Canada. Healthcare facilities and medical distributors should identify and isolate any affected kits from use.

Customers who have received these kits should contact Medline Industries for replacement or return instructions. Healthcare providers should ensure affected kits are not used in patient care.

The recalled product

Product
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedure Kits
Hazard
  • syringe-leakage
  • syringe-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 (6)

  • 1) Pack Number DYNJ62734A: UDI/DI 10193489242225 (each) 40193489242226 (case)
  • Lot Number 21IME904A
  • 2) Pack Number DYNJ44115A: UDI/DI 10889942308187 (each) 40889942308188 (case)
  • Lot Number 21EMF484A
  • 3) Pack Number DYNJ68393A: UDI/DI 10193489939996 (each) 40193489939997 (case)
  • Lot Number 22KBW583A

Distribution

Distributed nationwide across the United States.

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