COAPTIUM CONNECT Recall Issued for Shelf Life Labeling
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
TISSIUM SA is recalling COAPTIUM CONNECT devices because the labeled 36-month shelf life is not supported by real-time data and will be revised to 26 months.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
TISSIUM SA is conducting a voluntary recall of COAPTIUM CONNECT devices after determining that the currently labeled shelf life of 36 months is not substantiated by real-time data. The devices will be relabeled to reflect a revised shelf life of 26 months.
Which Products Are Affected
The recall affects COAPTIUM CONNECT (Brand Name: COAPTIUM CONNECT), Model/Catalog Number NCOCO4010, an in situ polymerizing peripheral nerve repair device. Affected lot numbers are 251000041, 250700048, 260300046, 260400050, and 260300047 (UDI-DI 03760279380148). Distribution was limited to US Nationwide in the states of CA, FL, IL, NJ, OH, and PA. Recall number Z-2906-2026.
What You Should Do
Consumers and healthcare providers should check inventory for the affected lots and follow instructions provided in the firm's notification letter for relabeling or return.
Why This Matters
Use of the device beyond its validated shelf life may result in perioperative breakage rendering the device unusable, with worst-case outcome of revision surgery.
Source
FDA recall number Z-2906-2026 (Class II).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,116 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.