Impact vessel sealers recalled over residual material that may dislodge
Medline is recalling 58,499 reprocessed LigaSure Impact sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
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: Scored 3 under the risk-of-harm criterion: residual material that can dislodge from a surgical instrument is a foreign body hazard, and no injuries are reported.
Plain-English summary
The Medline Renewal LigaSure Impact Sealer/Divider NanoCoated, compatible with the FT10 generator, 18 cm, FT10 SW version 4.0.1.15 or lower, a reprocessed laparoscopic and endoscopic electrosurgical accessory, is being recalled.
Medline Renewal determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
The recall covers 58,499 units across all lots, carrying UDI/DI 10888277680449 for each unit and 20888277680446 for the case. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
Material dislodging from an instrument during surgery could enter the patient. The enforcement record reports no injuries. Facilities should follow Medline's instructions.
The recalled product
- Product
- Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Manufacturer
- Medline Industries, LP
- Affected units
- 58,499
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 10888277680449 (each)
- 20888277680446 (case)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medline Industries, LP 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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