—#205335

Product

ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K163454
Affected lot / code info: UDI-DI 10705036014928 Lots 442C02 and 442C03

Why it was recalled

There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Blue Ash, Ohio 45242-2803

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Brazil.

Timeline

Recall initiated: 2023-12-11
Posted by FDA: 2024-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.