Electrosurgical Devices Recalled for Incomplete Packaging Tray Seal
Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 designation with no reported illnesses or injuries. The hazard is a packaging defect on sterile medical device packaging, which is precautionary in nature. This meets the criteria for Moderate severity as a low-risk issue on a Class II device without reported incidents.
Plain-English summary
Medline Industries, LP is recalling its ReNewal brand reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices (REF LF1844CR) due to incomplete seals on their packaging trays. The recall affects 11 units with lot number 498004 distributed in the United States.
The incomplete seal on the packaging tray is the issue prompting this recall. Healthcare facilities and individuals possessing affected devices should contact Medline Industries for return or replacement instructions.
For additional information, refer to FDA recall number Z-0117-2024.
The recalled product
- Product
- MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 11
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 (3)
- UDI/DI 10888277680418 (each)
- 20888277680415 (case)
- Lot Numbers: 498004
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.
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