The Recall Desk
ModerateFDA (Devices)·Z-2702-2024·Announced 2024-08-28

Medline Dental Procedure Kits Recalled Due to Dimensional Variation

Medline Industries is recalling certain dental procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 99 units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a dimensional fit issue without reported illnesses or injuries. The hazard is theoretical—potential difficulty in use—placing it in the Moderate severity category per the rubric.

Plain-English summary

Medline Industries, LP is recalling Medline dental procedure kits (DENTAL, REF DYNJ909211A) due to a dimensional variation in the product design.

The dimensional variation creates the potential for increased difficulty when fitting the kits into the outer canister. No injuries or adverse events have been reported to date.

The recall affects 99 units of the affected product with lot numbers 23IBU257 and 23KBR755. These kits were distributed worldwide including the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore.

Healthcare facilities and end users in possession of affected dental kits should stop using them and contact Medline Industries for a replacement or return. The product UDI is 40195327493234 (case) and 10195327493233 (unit).

The recalled product

Product
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • fit-issue
  • dimensional-variation

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 (5)

  • REF DYNJ909211A
  • UDI/DI 40195327493234 (case)
  • 10195327493233 (unit)
  • Lot Numbers: 23IBU257
  • 23KBR755

Distribution

Distributed nationwide across the United States.