The Recall Desk
HighFDA (Devices)·Z-1593-2025·Announced 2025-04-23

Medline Convenience Kits Recalled Due to Weak Breather Pouch Seals

Medline Industries is recalling multiple convenience kit models due to potential open or weak seals on breather pouches used for packaging. The compromised seals may allow sterility to be compromised on these medical device kits distributed nationwide and internationally.

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 sterile medical device kits where compromised packaging seals create a risk of harm by potentially allowing loss of sterility. No reported illnesses or injuries are mentioned in the source, but the hazard is direct and involves high-risk products (sterile procedural kits) where breach of sterility could lead to serious infection.

Plain-English summary

Medline Industries, LP is recalling 3,808 units of 16 different convenience kit models used for various medical procedures. The recall affects multiple product lines including line insertion packs, PICC line insertion kits, lumbar puncture trays, and central line insertion kits.

The recall is due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile convenience kits. Breather pouches are designed to maintain sterility, and compromised seals could affect the sterile integrity of the products.

The affected convenience kits have been distributed worldwide, including the United States nationwide and the countries of Canada, Mexico, Panama, and the Virgin Islands. A complete list of affected model numbers, lot numbers, and UDI codes is available from Medline Industries.

Healthcare facilities and users of these convenience kits should stop using affected units and contact Medline Industries for replacement or additional guidance.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ8243
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Procedural Kits
Hazard
Affected units
3,808

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) DYNJ44949C
  • UDI-DI: 10193489769227(each)
  • 40193489769228(case)
  • Lot Number: 24IBS279
  • 2) DYNJ41682C
  • UDI-DI: 10198459085512(each)
  • 40198459085513(case)
  • Lot Number: 24JBM452
  • 3) DYNJ81267A
  • UDI-DI: 10195327352356(each)
  • 40195327352357(case)
  • Lot Number: 24JBO094
  • 4) DYNJ82437A
  • UDI-DI: 10198459111006(each)
  • 40198459111007(case)
  • Lot Number: 24JBT077
  • 5) CDS980379J
  • UDI-DI: 10195327054908(each)
  • 40195327054909(case)
  • Lot Number: 24JBT886

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

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Same hazard · sterility breach

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