FDA (Devices) recall action 99345

TISSIUM SA recalled 8 products on 2026-08-12

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2026-08-12
Critical: 0
Units: —

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2026-08-12
COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
Product
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Category
Distribution
6 states
HighFDA (Devices)··2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states
HighFDA (Devices)··2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states
HighFDA (Devices)··2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2026-08-12
COAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2026-08-12
COAPTIUM CONNECT medical device shelf life recalibration recall
TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.
Product
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
Category
Distribution
6 states
HighFDA (Devices)··2026-08-12
Tissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states
HighFDA (Devices)··2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Distribution
6 states