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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 165
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.
Part of a larger recall action
This product is one of 33 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.
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