Recall Z-0470-2026— Medline Industries, LP

Name: FDA recall Z-0470-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-01

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2025-10-01. It names one FDA 510(k) clearance: K162751. Product: Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed. Reason: Medline Renewal has 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2025-10-01
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K162751 — Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.·cleared 2017-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Reason for recall

Medline Renewal has 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.