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Recall Observatory FDA recall evidence

Device 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

Z-0470-2026

October 01, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 97822
Status
Ongoing
Classification
Class II
Quantity
18,117 units
Official record key
device-enforcement:Z-0470-2026

Official wording

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.

Code information: UDI/DI 10888277680326 (each), 20888277680323 (case), All Lots

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.