Medline ReNewal Ligasure Maryland Jaw Sealer devices recalled for incomplete packaging seals
Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.
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: This is a Class II FDA recall with no reported illnesses or injuries. The hazard is a manufacturing defect (incomplete packaging seal) that is preventive in nature, without evidence of actual harm.
Plain-English summary
Medline Industries is recalling 58 units of the ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated electrosurgical instrument (REF LF1944CR). The affected devices have incomplete seals on their packaging trays.
The incomplete packaging seals may allow contamination of the devices during reprocessing steps. The recalled lot numbers are 498006, 498837, 498838, 499150, and 499151, identified by UDI/DI numbers 10888277719439 (individual) and 20888277719436 (case).
The recalled devices were distributed in the United States. Healthcare facilities that have received these devices should verify they have one of the affected lot numbers and contact Medline for instructions on return or replacement.
The recalled product
- Product
- MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 58
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 (7)
- UDI/DI 10888277719439 (each)
- 20888277719436 (case)
- Lot Numbers: 498006
- 498837
- 498838
- 499150
- 499151
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
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · incomplete packaging seal
See all →- ModerateMEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals
FDA (Devices) · 2023-10-25
Similar recalls
- HighMedline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal
FDA (Devices) · 2024-09-18
- HighMaryland jaw sealers 44 cm recalled over trapped residual material
FDA (Devices) · 2025-11-19
- HighMaryland jaw sealers 23 cm recalled over residual material inside the device
FDA (Devices) · 2025-11-19
- HighReprocessed vessel sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
- HighMedline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect
FDA (Devices) · 2024-09-18
- ModerateReprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect
FDA (Devices) · 2024-09-18