FDAClass II · Medical device · Recall Z-2903-2026 · Recalled August 12, 2026

Brand Name recall — TISSIUM SA

Agency report date: August 12, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Brand Name
Company / brand: TISSIUM SA
Lot / serial / date codes: Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034
Distribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.

Agency product description and boundaries

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect 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 device unusable; worst-case outcome would be revision surgery.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2903-2026
Brand: TISSIUM SA
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Brand Name

Companies & origin

Recalling firm location: Paris 12e Arrondissement, France
Firm address: 74 Rue Du Faubourg Saint-Antoine, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034
Distribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Firm notified the public via: Letter
FDA event ID: 99345
Recall initiated: June 15, 2026
FDA classified: August 6, 2026
FDA report date: August 12, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

Report a data error on this page