The Recall Desk
HighFDA (Devices)·Z-1609-2025·Announced 2025-04-23

Medline hernia repair kits recalled for weak packaging seals

Medline is recalling hernia repair kits due to potential open or weak seals on packaging pouches. The defect could compromise product sterility.

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 surgical kits with packaging seal defects. No illnesses or injuries reported, but the defect poses a risk of harm through potential loss of sterility, meeting the criteria for a high-severity risk-of-harm recall.

Plain-English summary

Medline Industries is recalling hernia repair convenience kits (Model DYNJ908337C, Lot 24KBK455) due to a defect in the packaging.

The recalled kits contain breather pouches with potential open or weak seals. Compromised seals could allow the packaged sterile items to lose their sterile condition, potentially exposing patients to contamination risks during surgery.

This recall affects 40 units distributed worldwide, including to the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands.

Healthcare facilities and surgical centers that received these kits should discontinue use and contact Medline for instructions on returning the affected products.

The recalled product

Product
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit
Hazard
  • packaging-seal-defect
  • contamination-risk

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 (4)

  • 1) DYNJ908337C
  • UDI-DI: 10198459085925(each)
  • 40198459085926(case)
  • Lot Number: 24KBK455

Distribution

Distributed nationwide across the United States.

Related recalls

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