CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Coaptium Connect recalled by Tissium
Tissium is recalling Coaptium Connect, distributed nationwide in the US. The recall was initiated on 15 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2908-2026
- FDA event ID
- 99345
- Recalling firm
- Tissium, Paris 12e Arrondissement
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jun 2026
- FDA classified
- 6 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 15 Jun 2026 | Recall initiated by company | |
| 6 Aug 2026 | Classified by FDA | +52 days |
| 12 Aug 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand 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
Where it was distributed
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Nationwide CaliforniaFloridaIllinoisNew JerseyOhioPennsylvania
Questions about this recall
Is Coaptium Connect recalled?
Yes. Tissium recalled Coaptium Connect on 15 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2908-2026.
Why was it recalled?
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.
Which lots are affected?
Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
Where was it sold?
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tissium
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Coaptium Connect recalled by Tissium | Tissium | Device Malfunction | Nationwide |
| Device | CLASS II | Coaptium Connect recalled by Tissium | Tissium | E. coli | Nationwide |
| Device | CLASS II | Coaptium Connect recalled by Tissium | Tissium | Device Malfunction | Nationwide |
| Device | CLASS II | Coaptium Connect recalled by Tissium | Tissium | Device Malfunction | Nationwide |
| Device | CLASS II | Coaptium Connect recalled by Tissium | Tissium | Device Malfunction | Nationwide |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |