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.
What this means for you
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
- packaging-defect
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.
Related recalls
Same category
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27