COAPTIUM CONNECT Recall Issued for Shelf Life Labeling
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TISSIUM SA is recalling COAPTIUM CONNECT devices due to unsubstantiated 36-month shelf life labeling, revising it 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 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.
Which Products Are Affected
The affected product is Brand Name: COAPTIUM CONNECT, Product Name: COAPTIUM CONNECT, Model/Catalog Number: NCOCO2010. It is an in situ polymerizing peripheral nerve repair device. Lot codes affected are 250700042, 251000033, and 251000034 (UDI-DI 03760279380094). Distribution is US Nationwide in the states of CA, FL, IL, NJ, OH, PA. Recall number Z-2903-2026. Classification: Class II.
What You Should Do
Consumers should follow instructions from the recalling firm regarding relabeled devices. The use of a medical device beyond its validated shelf life may result in perioperative breakage rendering the device unusable.
Why This Matters
The recall affects devices distributed across multiple U.S. states and addresses potential device failure requiring revision surgery in worst-case scenarios.
Source
FDA recall Z-2903-2026, TISSIUM SA, report date 20260812.
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 (1,164 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.