Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A…

Tissium Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TISSIUM SA · 74 Rue Du Faubourg Saint-Antoine · Paris 12e Arrondissement

Is this the product you have?

  • Brand NameCOAPTIUM
  • CONNECT Product NameCOAPTIUM
  • CONNECT Model/Catalog NumberNCOCO5010
  • Software VersionN/A
  • Product DescriptionIn situ polymerizing peripheral
  • nerve repair device ComponentNo
Lot codes and dates
  • Lot Code
    • Model No NCOCO5010
    • UDI-DI 03760279380179
    • Lot Numbers 250700050
    • 251000043
    • 260300048
    • 260300049
    • and 260300050

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.