FDA Device recall Z-3245-2026
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector by Olympus, citing potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3245-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Reason
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Identifiers
| code_info | Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Olympus
- Olympus M3 Gold Autoclavable Lateral Telescope 70
FDA Device · Class II · 2026-10-07 · Olympus - Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System
FDA Device · Class II · 2026-10-07 · Olympus - Olympus M3 Gold Autoclavable Foroblique Telescope 30
FDA Device · Class II · 2026-10-07 · Olympus - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
FDA Device · Class II · 2026-09-30 · Olympus
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3245-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.