The Recall Desk
HighFDA (Devices)·Z-0158-2025·Announced 2024-10-30

Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Medline Industries, LP is recalling 2,426 units of Medline brand medical procedure convenience kits. The affected products include various biopsy packs, trays, and kits, such as the Cone Biopsy Pack, Biopsy Tray, and CT Biopsy kit. These products were distributed nationwide in the United States, as well as in Canada and Panama.

The recall was initiated because certain convenience kits were packaged in breather pouches with lot number 323080002. It has been determined that if the vendor seal of these specific pouches is opened or unsealed, there is a potential risk that the product inside may be non-sterile. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and consumers should check their inventory for the specific reference numbers and lot numbers listed in the recall notice. If the products are found, they should be removed from use and returned to Medline Industries, LP for credit or replacement according to the company's instructions.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
Affected units
2,426

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 DYNJ17534L
  • UDI/DI 40195327258253 (each)
  • 10195327258252 (case)
  • Lot Numbers: 23KBF936
  • b) REF DYNJ43076A
  • UDI/DI 40195327080625 (each)
  • 10195327080624 (case)
  • Lot Numbers: 23LBI584
  • c) REF DYNJ49404C
  • UDI/DI 40195327395453 (each)
  • 10195327395452 (case)
  • Lot Numbers: 23LBP833
  • d) REF DYNJ52666C
  • UDI/DI 40193489452144 (each)
  • 10193489452143 (case)
  • Lot Numbers: 23LBN740
  • e) REF DYNJ61130B
  • UDI/DI 40195327054589 (each)
  • 10195327054588 (case)
  • Lot Numbers: 23LBP401

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 · sterility compromise

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