The Recall Desk
ModerateFDA (Devices)·Z-2697-2024·Announced 2024-08-28

Medline Medical Soft Liner Recall Due to Dimensional Variation

Medline Industries recalls 1.5L medical soft liners due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 88,703 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 defect affecting product assembly. No injuries, illnesses, or hospitalizations have been reported. The hazard is functional difficulty rather than an acute safety risk.

Plain-English summary

Medline Industries, LP is recalling its 1.5L MED-SOFT LINER W/ 6MM X 1.8M TUB. & ADULT VC (ref OR53926) due to a slight dimensional variation in the product.

The dimensional variation has the potential to cause increased difficulty when fitting the device into its outer canister. This defect may affect proper assembly and use of the device.

The recall affects 88,703 units that were distributed worldwide, including throughout the United States, Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Affected lot numbers are: 670220512, 670220609, 670220621, 670220629, 670220712, 670220803, 670220815, 670220914, and 670221009.

Consumers and healthcare facilities using this product should discontinue use of affected units. Contact Medline Industries for instructions on returning or replacing the product.

The recalled product

Product
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • fitting-defect
  • dimensional-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 (11)

  • UDI/DI 40888277422279 (package)
  • 0888277DC265NSKX (unit)
  • Lot Numbers: 670220512
  • 670220609
  • 670220621
  • 670220629
  • 670220712
  • 670220803
  • 670220815
  • 670220914
  • 670221009

Distribution

Distributed nationwide across the United States.