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Lower risk Medical device recall · FDA · Published June 15, 2026

COAPTI: Connect devices with 26-month shelf life update to prevent breakage

COAPTIUM Connect devices with model NCOCO1510 have a revised shelf life from 36 to 26 months to prevent perioperative breakage during surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2901-2026Medical deviceCOAPTIUM Connect ›
✎ GovInfoNow plain-language explainer

COAPTIUM Connect devices with model NCOCO1510 have a reduced shelf life from 36 to 26 months. Using them beyond this period risks device breakage during surgery, potentially requiring revision surgery. Read more at govinfonow.com/recall/314357-coapti-connect-devices-with-26-month-shelf-life-update-to.

Source Summary by GovInfoNow · govinfonow.com/recall/314357-coapti-connect-devices-with-26-month-shelf-life-update-to · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2901-2026

Cite this page

“COAPTI: Connect devices with 26-month shelf life update to prevent breakage.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314357-coapti-connect-devices-with-26-month-shelf-life-update-to. Based on FDA recall #Z-2901-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2901-2026%22&limit=1).

TISSIUM SA recalled the COAPTIUM Connect peripheral nerve repair device (Model NCOCO1510) because its labeled 36-month shelf life is not substantiated by real-time data, according to the FDA. The agency announced the Class II recall on June 15, 2026.

How to tell if you have it

  • Brand: COAPTIUM Connect
  • Product Name: COAPTIUM Connect
  • Model/Catalog Number: NCOCO1510
  • Lot Numbers: 250700041 and 251000032
  • UDI-DI: 03760279380070

The hazard

The use of the device beyond its validated shelf life may result in perioperative breakage, rendering it unusable. The worst-case outcome would be revision surgery.

Context

GovInfoNow's records show other recent recalls of similar products include Cook Medical Approach CTO-6 Micro Wire Guide (2026-03-05), Cook Medical Approach CTO-18 Micro Wire Guide Recall (2026-03-05) and Cook Medical Approach CTO-12 Micro Wire Guide (2026-03-05).

How to tell if you have this one

Check for model number NCOCO1510 on the device. Devices sold with lot numbers 250700041 or 25100032 are affected.

  • Brand
    COAPTIUM Connect
  • Category
    Medical device
FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Recall numberProduct, codes & lotsQuantity
Z-2901-2026Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A; Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032—
Z-2902-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041—
Z-2903-2026Brand 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; Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034—
Z-2904-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043—
Z-2905-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064—
Z-2906-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047—
Z-2907-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050—
Z-2908-2026Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No; Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045—
Based on the official FDA remedy

What to do — step by step

  1. Check Shelf Life

    Verify the device's current shelf life label; if it shows 36 months, it is affected and needs relabeling to 26 months.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Illinois, New Jersey, Ohio, Pennsylvania.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Jun 15, 202612. FDA classified it Class II: Aug 6, 202623. Published in FDA’s Enforcement Report: Aug 12, 202634. Added to GovInfoNow: Aug 18, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Why is the shelf life being reduced?

The manufacturer found that the original 36-month shelf life wasn't supported by real-time data, so they revised it to 26 months to ensure device safety.

Do I need to do anything if my device shows 26 months?

No action is needed; the device is safe to use within its updated 26-month shelf life.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2901-2026 (June 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2901-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA