The Recall Desk
HighFDA (Devices)·Z-1436-2025·Announced 2025-04-02

Medline Procedure Kits Recalled Due to Defective Plastic Syringes

Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in 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 without reported illnesses, injuries, or hospitalizations. Leaking or breaking syringes in medical procedures represent a risk-of-harm scenario where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling multiple angiography and catheterization procedure kits containing plastic syringes. The recalled kits were distributed nationwide in the United States and in Canada, affecting a total of 1939 units.

The plastic syringes in these kits have been identified with quality issues including leaks and breakage. The FDA identified these issues in a safety alert issued on March 19, 2024. These defects may pose a risk to patient health during medical procedures.

Healthcare providers should verify whether they have received any of the affected kits and follow appropriate procedures regarding recalled medical devices.

The recalled product

Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Angiography/Catheterization Kits
Hazard
  • syringe-leak
  • syringe-breakage
  • device-malfunction

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 DYNJ50624A: UDI/DI 10889942474639 (each) 40889942474630 (case)
  • Lot Number 20BDB393A
  • 2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case)
  • Lot Number 21HBP134A
  • Lot Number 21GMA850A
  • 4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case)
  • Lot Number 21IMD296A
  • 5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case)
  • Lot Number 21BBI114A
  • 6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case)
  • Lot Number 23EBE560A
  • 7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case)
  • Lot Number 21AMA569A
  • 8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case)
  • Lot Number 21GMB606A
  • 9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case)
  • Lot Number 23CLA070A
  • 10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case)
  • Lot Number 21IME955A
  • 11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category