The Recall Desk
HighFDA (Devices)·Z-0178-2025·Announced 2024-10-30

Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk

Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.

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 where packaging seal defects could result in non-sterile product being used in surgical procedures. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for High severity.

Plain-English summary

Medline Industries is recalling certain medical procedure convenience kits that were packaged in breather pouch lot 323080002. These kits are used in ophthalmic (eye) and other surgical procedures.

The recalled kits may contain non-sterile product if the vendor seal of the breather pouch is opened or unsealed. Sterility is critical for surgical instruments and supplies, as non-sterile products could introduce contamination and result in serious infection or surgical complications.

The recall affects 27,906 units distributed worldwide, including the United States, Canada, and Panama. Healthcare facilities and consumers should not use affected kits and should contact Medline Industries for replacement or further instructions.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedure convenience kits
Hazard
  • non-sterile
  • contamination

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) REF DYNJ19492L
  • UDI/DI 40195327368587 (each)
  • 10195327368586 (case)
  • Lot Numbers: 24ABE741
  • 2) REF DYNJ22354L
  • UDI/DI 40195327239924 (each)
  • 10195327239923 (case)
  • Lot Numbers: 23LBN139
  • 3) REF DYNJ24573K
  • UDI/DI 40195327144303 (each)
  • 10195327144302 (case)
  • Lot Numbers: 23KBB931
  • 4) REF DYNJ30327A
  • UDI/DI 40193489997089 (each)
  • 10193489997088 (case)
  • Lot Numbers: 24ABB714
  • 5) REF DYNJ36868F
  • UDI/DI 40888277897060 (each)
  • 10888277897069 (case)
  • Lot Numbers: 23KBD160

Distribution

Distributed nationwide across the United States.

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