The Recall Desk
HighFDA (Devices)·Z-1438-2025·Announced 2025-04-02

Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits 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 surgical procedure kits with identified defects (leaks, breakage) in plastic syringes. No injuries have been reported, but the defects pose potential risk to patients in surgical procedures, fitting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 3,860 surgical procedure kits containing plastic syringes with quality defects. The recall affects 73 different Medline procedure kit models used in cardiac, vascular, and pacemaker surgical procedures.

The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Identified defects include leaks and breakage that may pose a risk to patient health.

The recalled kits have been distributed nationwide in the United States and in Canada.

The recalled product

Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • syringe-leak
  • syringe-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 (20)

  • 1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case)
  • Lot Number 23DBG477A
  • 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case)
  • Lot Number 23LMD975A
  • 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case)
  • Lot Number 22GBV822Z
  • 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case)
  • Lot Number 22GMB113A
  • 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case)
  • Lot Number 21JMG551A
  • 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case)
  • Lot Number 23JBH403A
  • 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case)
  • Lot Number 21LBJ158A
  • 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case)
  • Lot Number 24AMF039A
  • 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case)
  • Lot Number 23LMF122A
  • Lot Number 22CMB582A
  • 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case)

Distribution

Distributed nationwide across the United States.

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