FDA Classifies COAPTIUM CONNECT Recall as Class II Hazard
The FDA has classified the ongoing recall of COAPTIUM CONNECT nerve repair devices as Class II due to unsubstantiated shelf-life labeling.
3 reports on this incident · first at Aug 18, 2026, 2:41 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
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Earlier reports
Aug 18, 2026, 2:58 a.m. ET
FDA Reports Class II Recall for TISSIUM COAPTIUM CONNECT Devices Over Shelf-Life Labeling
FDA enforcement records report an ongoing Class II recall for COAPTIUM CONNECT peripheral nerve repair devices manufactured by TISSIUM SA. The firm initiated the voluntary action on June 15, 2026, and the FDA published enforcement report Z-2903-2026 on August 12, 2026. The FDA defines a Class II recall as a situation where product exposure may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recall affects Model No NCOCO2010 with UDI-DI 03760279380094 and Lot Numbers 250700042, 251000033, and 251000034. According to FDA enforcement documentation, the device's currently labeled shelf life of 36 months is not substantiated by real-time data, and affected devices will be relabeled to reflect a revised shelf life of 26 months. Using the device beyond its validated shelf life may result in perioperative breakage that renders it unusable, with a worst-case outcome of revision surgery. Distribution of the affected lots occurred in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
Registry and regulatory documentation indicate COAPTIUM CONNECT is a prescription-only surgical device used by surgeons during operations on severed peripheral nerves accommodating nerve diameters up to 6 mm. It is supplied to hospital operating rooms and is not a consumer product. FDA database records list no other enforcement actions for TISSIUM SA.
Aug 18, 2026, 2:41 a.m. ETFirst report
FDA Reports Class II Recall of COAPTIUM CONNECT Nerve Repair Devices
An ongoing Class II recall has been initiated for specific lots of COAPTIUM CONNECT peripheral nerve repair devices manufactured by TISSIUM SA, according to FDA enforcement report Z-2903-2026 published August 12, 2026. The recall action was initiated on June 15, 2026, and remains open and developing. According to official FDA guidance, a Class II recall is designated for situations where exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.
Official enforcement records state that the device's currently labeled 36-month shelf life is not substantiated by real-time data, and affected units will be relabeled to state a revised shelf life of 26 months. The FDA record notes that using the device beyond its validated shelf life may result in perioperative breakage, rendering it unusable, with a worst-case outcome of revision surgery. The recall covers Model/Catalog Number NCOCO2010 with UDI-DI 03760279380094 and Lot Numbers 250700042, 251000033, and 251000034. Nationwide U.S. distribution occurred in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
According to FDA de novo classification review records, COAPTIUM CONNECT is a sterile, single-use, prescription-only surgical implant kit used in operating rooms to reconnect cut peripheral nerves up to 6 mm in diameter without stitches. It consists of a 3D-printed coaptation chamber and a photo-activated polymer hardened with a 405 nm blue-light pen. The prescription device is supplied directly to hospitals and surgical facilities, and FDA enforcement records list no other historical recall actions for TISSIUM SA.
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Revision history
- Version 118 Aug 2026, 06:41current
First published.
- Version 118 Aug 2026, 07:26current
First published.
- Version 118 Aug 2026, 06:58current
First published.
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