CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

Coaptium Connect recalled by Tissium

Tissium is recalling Coaptium Connect, distributed nationwide in the US. The recall was initiated on 15 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2908-2026
FDA event ID: 99345
Recalling firm: Tissium, Paris 12e Arrondissement
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jun 2026
FDA classified: 6 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

15 Jun 2026	Recall initiated by company
6 Aug 2026	Classified by FDA	+52 days
12 Aug 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.

Nationwide California Florida Illinois New Jersey Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 99345

This product is part of a recall event; the main page for the event is Coaptium Connect recalled by Tissium.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide

More recalls from Tissium

All 8

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Coaptium Connect recalled by Tissium	Tissium	Device Malfunction	Nationwide

Other Medical Software recalls

All 908

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg	PTW Freiburg	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide