FDA Medical devices recall ·
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated… recall
- Recall number
- Z-0475-2026
- Date
- (initiated October 1, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,007 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10888277719392 (each), 20888277719399 (case), All Lots
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0475-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.