COAPTIUM CONNECT Device Recall by TISSIUM
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 peripheral nerve repair devices due to unsubstantiated 36-month shelf life labeling.
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-devices.
What Happened
TISSIUM SA initiated a voluntary recall because the currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect a 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 it unusable; worst-case outcome would be revision surgery.
Which Products Are Affected
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 UDI-DI: 03760279380100 Lot Numbers: 250700016, 251000048, 251000049, and 260300043 Product Description: In situ polymerizing peripheral nerve repair device Distribution: US Nationwide in CA, FL, IL, NJ, OH, PA Recall Number: Z-2904-2026 Classification: Class II
What You Should Do
Consumers should verify lot codes on affected devices and follow instructions from the recalling firm regarding relabeling or returns.
Why This Matters
Use beyond the validated shelf life could lead to device breakage requiring potential revision surgery.
Source
FDA recall Z-2904-2026, https://www.fda.gov
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 (1,126 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.