The Recall Desk
HighFDA (Devices)·Z-0159-2025·Announced 2024-10-30

Medline dental pack may contain non-sterile product due to packaging defect

Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.

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 with no reported hospitalizations or injuries. The hazard is theoretical—non-sterile product exposure—contingent on seal compromise with no known incidents. Per the rubric, theoretical hazards without reported illness score at most 3 (High).

Plain-English summary

Medline Industries, LP is recalling certain dental procedure convenience kits (model DYNJ64086B) that were packaged in breather pouches with lot number 323080002. The recall was issued because these kits may result in potential use of non-sterile product if the breather pouch's vendor seal is opened or unsealed.

This Class II recall affects 165 units distributed in the United States, Canada, and Panama. The FDA is overseeing the recall.

Individuals or healthcare facilities with affected kits should contact Medline Industries for further information and instructions.

The recalled product

Product
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Dental supplies
Hazard
  • non-sterile-product
  • packaging-defect

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 (3)

  • UDI/DI 40195327120420 (each)
  • 10195327120429 (case)
  • Lot Numbers: 24ABF266

Distribution

Distributed nationwide across the United States.

Related recalls

Same category