Z-0473-2026Class II
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-10-01 / Open, Classified
Medline Industries, LP began a recall of Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0473-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Product code
- NUJ 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.
- FDA root cause
- Under Investigation by firm
- Action
- Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail. The notice explained the issue, potential risk to health, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-206 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."
- Quantity in commerce
- 60,917 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- UDI/DI 10888277680395 (each), 20888277680392 (case), All Lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0467-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0468-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0469-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0470-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0471-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0472-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0473-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0474-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0475-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0476-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0477-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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