The Recall Desk
ModerateFDA (Devices)·Z-2695-2024·Announced 2024-08-28

Medline soft suction canister liner dimensional variation causes difficult fitting

Medline recalls suction canister liners with dimensional variation that may cause fitting difficulties.

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: FDA Class II recall with a dimensional defect causing potential fitting difficulty. No injuries or illnesses reported, making this a low-risk functional issue.

Plain-English summary

Medline Industries, LP is recalling LINER, SOFT, SUCTION CANISTER, 1500CC (Reference OR929K). The recalled units have a slight dimensional variation that may cause increased difficulty when inserting the liner into the outer canister.

The affected product was distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore.

Healthcare facilities and consumers using affected units should contact Medline Industries, LP for instructions. Lot numbers and UDI codes to identify affected units are documented by the manufacturer.

The recalled product

Product
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • fitting-difficulty
  • 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 (10)

  • UDI/DI 40888277276209 (package)
  • 10888277276208 (unit)
  • Lot Numbers: 670220928
  • 670220928
  • 670221020
  • 670221010
  • 670221121
  • 670221128
  • 670230317
  • 670230419

Distribution

Distributed nationwide across the United States.