The Recall Desk
HighFDA (Devices)·Z-0165-2025·Announced 2024-10-30

Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk

Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from 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: FDA Class II device recall with a theoretical risk of non-sterile product use if the protective pouch seal is compromised. No illnesses, injuries, or deaths have been reported, making this a risk-of-harm scenario without actual reported harm.

Plain-English summary

Medline Industries is recalling 1,048 medical procedure convenience kits distributed nationwide in the United States, as well as in Canada and Panama. The affected kits were packaged with breather pouches bearing lot number 323080002.

The recall was initiated because these kits may become non-sterile if the vendor seal on the breather pouch is opened or compromised. Non-sterile medical procedure kits pose a risk of contamination if used in medical procedures.

The recalled kits include multiple SKUs with various reference numbers, including breast biopsy packs, septoplasty packs, and other surgical procedure kits. Affected lot numbers are listed by product type and reference number.

Healthcare facilities and healthcare providers should immediately stop using any affected kits and contact Medline Industries for replacement or disposal instructions.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
Affected units
1,048

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) DYNJ42735A
  • UDI/DI 40888277226433 (each)
  • 10888277226432 (case)
  • Lot Numbers: 23LBP975
  • b) DYNJ43457
  • UDI/DI 40888277055309 (each)
  • 10888277055308 (case)
  • Lot Numbers: 23LBS052
  • c) DYNJ46717A
  • UDI/DI 40193489650014 (each)
  • 10193489650013 (case)
  • Lot Numbers: 24ABF270
  • d) DYNJ46717A
  • Lot Numbers: 23LBO013
  • e) DYNJ53205B
  • UDI/DI 40193489424851 (each)
  • 10193489424850 (case)
  • Lot Numbers: 24ABC805
  • f) DYNJ53205B
  • Lot Numbers: 23LBN742

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

See all →

Same hazard · non sterile

See all →