The Recall Desk
ModerateFDA (Devices)·Z-0119-2024·Announced 2023-10-25

MEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals

MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.

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 recall involving incomplete packaging seals on surgical instruments. The hazard is precautionary in nature—incomplete seals on sterile device packaging present a potential sterility risk—with no documented adverse outcomes reported.

Plain-English summary

MEDLINE INDUSTRIES is recalling MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated units (REF LF4418CR) compatible with FT10 generators. The recall involves reprocessed surgical instruments originally manufactured by Covidien and Ethicon.

The units may have incomplete seals on the packaging tray. An incomplete seal could compromise the sterility of the device.

The recall affects 268 units distributed in the United States. Affected lot numbers include: 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, and 499343.

Consumers who have received affected units should stop using them and contact MEDLINE INDUSTRIES for further instructions.

The recalled product

Product
MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Electrosurgical
Hazard
Affected units
268

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 (20)

  • UDI/DI 10193489189759 (each)
  • 20888277680446 (case)
  • Lot Numbers: 498352
  • 498405
  • 498459
  • 498890
  • 498937
  • 499048
  • 499050
  • 499052
  • 499062
  • 499063
  • 499145
  • 499155
  • 499218
  • 499267
  • 499269
  • 499271
  • 499299
  • 499343

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · incomplete packaging seal

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