Medline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal
Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or hospitalizations. The hazard—incomplete packaging seals—is a risk-of-harm to product sterility assurance but remains theoretical with no actual adverse events reported, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling 2,860 units of the ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated (Item Number: LF1937CR), nationwide.
The recall was initiated because of a potential for incomplete seals on the packaging tray. An incomplete seal could compromise the device's sterility assurance.
Affected lot numbers range from 487233 to 518625 (146 specific lots identified). Healthcare facilities and distributors should verify their inventory against the recall list and follow Medline Industries' instructions regarding the affected devices.
The recalled product
- Product
- Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 2,860
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)
- Item Number: LF1937CR. UDI/DI: 20888277719412 (case)
- 10888277719415 (each). Lot Numbers: 487233
- 487315
- 500686
- 500687
- 500963
- 507070
- 507116
- 507420
- 507423
- 507424
- 513684
- 513691
- 513692
- 513998
- 513999
- 514002
- 514004
- 514006
- 514205
Distribution
Distributed nationwide across the United States.
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
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