The Recall Desk
ModerateFDA (Devices)·Z-2710-2024·Announced 2024-08-28

Medline Procedure Kits Recalled Due to Dimensional Fitting Issues

Medline is recalling 160 medical procedure kits due to a dimensional variation that may make them difficult to fit into their outer canister. No injuries have been reported.

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 a Class II medical device recall involving a dimensional variation that affects fitting. No illnesses or injuries have been reported, and the hazard is theoretical. This manufacturing defect warrants precautionary recall, consistent with Moderate severity.

Plain-English summary

Medline Industries, LP is recalling 160 TURNOVER KIT medical procedure kits (Reference DYKC1289F, Lot 23LBF766) distributed worldwide. The kits are subject to recall due to a slight dimensional variation that has the potential for increased difficulty fitting into the outer canister.

The affected kits were distributed to the United States and internationally to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore.

To date, no illnesses or injuries have been reported. Users or facilities that have received these kits should contact Medline Industries for further instructions regarding the recall.

The recalled product

Product
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • dimensional-variation
  • fitting-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 (4)

  • a) REF DYKC1289F
  • UDI/DI 40195327510917 (case)
  • 10195327510916 (unit)
  • Lot Numbers: 23LBF766

Distribution

Distributed nationwide across the United States.