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
- Hazard
- incomplete-packaging-seal
- sterility-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 (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.
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