The Recall Desk
HighFDA (Devices)·Z-2224-2024·Announced 2024-07-10

Medline surgical convenience kits recalled for weak seal defects

Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.

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 recall of sterile medical devices. No injuries or illnesses have been reported. The weak seals pose a theoretical risk of sterility breach during surgical procedures, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP has recalled 12,588 sterile surgical convenience kits due to a defect in the Pure Pouch component. These convenience packs include multiple types of surgical kits used in catheterization, angiography, and other medical procedures, each containing various sterile surgical instruments.

The Pure Pouch component in these kits has weak seals that may result in a breach of sterility if the seal fails. A compromised sterile field could lead to contamination of the surgical instruments inside, posing a risk to patients undergoing medical procedures.

The affected kits were distributed nationwide to healthcare facilities in 23 states: Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming.

Healthcare facilities that received these kits should stop using them immediately and contact Medline Industries for replacement or credit. The FDA encourages healthcare providers and consumers to report any adverse events related to this recall to the agency.

The recalled product

Product
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Sterile Kits
Hazard
Affected units
12,588

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. Pack #00-RDF0360 - lot numbers 24AMF652
  • exp. 11/30/2026
  • 23IMD552
  • exp. 6/30/2026
  • and 23DMI750
  • exp. 7/31/2025
  • UDI-DI each-10195327195618
  • UDI-DI case-40195327195619. b. Pack #DYNJ26488W - lot number 23EDA461
  • exp. 10/31/2025
  • UDI-DI each-10195327209780
  • UDI-DI case-40195327209781. c. Pack #DYNJ30927Q - lot numbers 23IMB725
  • exp. 4/30/2026
  • and 23GMI473
  • exp. 1/31/2026
  • UDI-DI each-10195327164225
  • UDI-DI case-40195327164226. d. Pack #DYNJ30927R - lot numbers 23LMH572
  • exp. 5/31/2026
  • 23KMH917
  • 23KMD083
  • and 23KMB895

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · weak seal

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