The Recall Desk
ModerateFDA (Devices)·Z-0118-2024·Announced 2023-10-25

Medline ReNewal Ligasure Maryland Jaw Sealer devices recalled for incomplete packaging seals

Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.

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 FDA recall with no reported illnesses or injuries. The hazard is a manufacturing defect (incomplete packaging seal) that is preventive in nature, without evidence of actual harm.

Plain-English summary

Medline Industries is recalling 58 units of the ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated electrosurgical instrument (REF LF1944CR). The affected devices have incomplete seals on their packaging trays.

The incomplete packaging seals may allow contamination of the devices during reprocessing steps. The recalled lot numbers are 498006, 498837, 498838, 499150, and 499151, identified by UDI/DI numbers 10888277719439 (individual) and 20888277719436 (case).

The recalled devices were distributed in the United States. Healthcare facilities that have received these devices should verify they have one of the affected lot numbers and contact Medline for instructions on return or replacement.

The recalled product

Product
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • incomplete-packaging-seal
  • contamination-risk

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 (7)

  • UDI/DI 10888277719439 (each)
  • 20888277719436 (case)
  • Lot Numbers: 498006
  • 498837
  • 498838
  • 499150
  • 499151

Distribution

Distribution scope not specified by the agency.