COAPTIUM Connect Device Recall Issued
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 specific lots of COAPTIUM Connect due to unsubstantiated 36-month shelf life labeling, which 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, device.
What Happened
TISSIUM SA initiated a voluntary recall because the currently labeled shelf life of 36 months for the COAPTIUM Connect device 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: NCOCO1510. Product Description: In situ polymerizing peripheral nerve repair device. Lot Numbers: 250700041 and 251000032. UDI-DI: 03760279380070. Distribution: US Nationwide in the states of CA, FL, IL, NJ, OH, PA. Recall Number: Z-2901-2026. Classification: Class II.
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. Contact TISSIUM SA for further guidance on affected devices.
Why This Matters
The recall addresses potential device breakage if used beyond the validated shelf life, which could lead to revision surgery in the worst case.
Source
FDA recall Z-2901-2026 (event ID 99345).
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 (1,294 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.