The Recall Desk
HighFDA (Devices)·Z-0155-2025·Announced 2024-10-30

Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product

Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.

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 involving medical devices used in invasive procedures with a potential for non-sterile product. No illnesses, injuries, or hospitalizations have been reported. The hazard is theoretical—a risk-of-harm product where injury has not yet been reported—placing it in the High category per the rubric.

Plain-English summary

Medline Industries is recalling certain medical procedure convenience kits due to a packaging defect that could allow them to become non-sterile. The affected kits include products used in radiology, cardiac catheterization, angiography, and interventional radiology procedures. The recall involves kits that were packaged in breather pouch lot 323080002.

The issue is that the vendor seal on the breather pouch may open or become unsealed, which could result in product sterility being compromised. If these non-sterile kits are used in medical procedures, they could pose a risk of infection to patients.

Approximately 1,460 units of affected medical procedure convenience kits have been distributed nationwide in the US and internationally to Canada and Panama. Healthcare facilities and consumers should stop using any kits packaged in breather pouch lot 323080002 and contact Medline Industries for replacement or further instructions.

The recalled product

Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Medical Procedure Kits
Hazard
Affected units
1,460

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)

  • a) REF DYNDH1609: UDI/DI 40193489844802 (each)
  • 10193489844801 (case)
  • Lot Numbers: 23LBO852
  • b) REF DYNJ19010I: UDI/DI 40888277858627 (each)
  • 10888277858626 (case)
  • Lot Numbers: 23LBK443
  • c) REF DYNJ29207: UDI/DI 40080196015413 (each)
  • 10080196015412 (case)
  • Lot Numbers: 23LBL962
  • d) REF DYNJ43661C: UDI/DI 40195327104353 (each)
  • 10195327104351 (case)
  • Lot Numbers: 23LBU931
  • e) REF DYNJ46746C: UDI/DI 40195327040162 (each)
  • 10195327040161 (case)
  • Lot Numbers: 23LBK374
  • f) REF DYNJ47667C: UDI/DI 40195327040179 (each)
  • 10195327040178 (case)
  • Lot Numbers: 23LBL629
  • g) REF DYNJ50712D: UDI/DI 40195327267927 (each)
  • 10195327267926 (case)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 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 33 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · non sterile

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