COAPTIUM CONNECT Device Recall
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 due to unsubstantiated shelf life labeling, affecting specific lots distributed in six U.S. states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 20, 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, Devices.
What Happened
TISSIUM SA initiated a voluntary recall because the labeled 36-month shelf life for the COAPTIUM CONNECT device is not supported by real-time data. Devices will be relabeled with a revised 26-month shelf life.
Which Products Are Affected
The recall involves the COAPTIUM CONNECT (Model/Catalog Number: NCOCO1575), an in situ polymerizing peripheral nerve repair device. Affected lots are 250700007, 251000031, and 260300041 (UDI-DI: 03760279380087). Distribution was limited to US Nationwide in the states of CA, FL, IL, NJ, OH, and PA. The recall number is Z-2902-2026.
What You Should Do
Consumers and healthcare providers should check inventory for the affected lots and contact TISSIUM SA for return or relabeling instructions. Do not use devices beyond the revised 26-month shelf life.
Why This Matters
Use of the device beyond its validated shelf life may result in perioperative breakage, rendering it unusable and potentially requiring revision surgery.
Source
FDA recall Z-2902-2026
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 (1,024 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 20, 2026.
Frequently Asked Questions
Common questions about this FDA recall.