FDAClass IIApril 9, 2025

Ethibond Excel GRN 36in(90cm) Usp2-0(m3) D/a MH recall

ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

Why was Ethibond Excel GRN 36in(90cm) Usp2-0(m3) D/a MH recalled?

Identified curing issues with the silicone during the needles manufacturing process.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: X843H-56; GMDN: 13906; UDI-DI: 10705031058088; Lot number: 10489X ;

Product
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Recalling firm
Ethicon Endo Surgery, LLC
Quantity
2,556 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Recall date
April 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls