The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1592-2025·Announced 2025-04-23

Medline Sterile Convenience Kits Recalled for Potential Weak Seals

Medline Industries is recalling multiple sterile surgical convenience kits because purchased breather pouches used in packaging may have open or weak seals, which could compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall involving sterile medical devices used in surgery; compromised packaging seals could result in sterility loss and risk of infection, representing a significant risk of harm to patients, though no illnesses or injuries are reported in the source.

Plain-English summary

Medline Industries, LP is recalling 3,205 units of multiple sterile surgical convenience kits due to a potential for open or weak seals on purchased breather pouches used for packaging. The breather pouches are part of the kit packaging system for these products.

The affected kits include 37 different model numbers, such as the DR. KHAN CABG ADDS PACK, CARDIAC STERNAL PACK, PACEMAKER PACK, EP PACK, and VASCULAR PACK variants, among others. These kits have been distributed worldwide, including to the US nationwide and to Canada, Mexico, Panama, and the Virgin Islands.

Affected customers who have purchased these kits should stop using them and contact Medline Industries for instructions. Healthcare facilities should verify the integrity of packaging seals before using any of the recalled kits. The FDA has classified this as a Class II recall.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION…
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Convenience Packs
Hazard
Affected units
3,205

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) DYNJ59310D
  • UDI-DI: 10195327402396(each)
  • 40195327402397(case)
  • Lot Number: 24IBB643
  • 2) DYNJ32436A
  • UDI-DI: 10884389686614(each)
  • 40884389686615(case)
  • Lot Number: 24IBG295
  • 3) DYNJ35586G
  • UDI-DI: 10193489663235(each)
  • 40193489663236(case)
  • Lot Number: 24IBG343
  • 4) DYNJ55343B
  • UDI-DI: 10195327478056(each)
  • 40195327478057(case)
  • Lot Number: 24IBG535
  • 5) DYNJ55343B
  • Lot Number: 24IBH248
  • 6) DYNJ65027B
  • UDI-DI: 10193489471991(each)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · weak seal

See all →

Similar recalls