CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled
Olympus Corporation of the Americas is recalling Olympus BiCOAG Hemostasis Probe Coaxial Connector, distributed nationwide in the US. The recall was initiated on 19 Aug 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-3246-2026
- FDA event ID
- 99609
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +30 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Product as listed by the FDA
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Questions about this recall
Why was it recalled?
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Which lots are affected?
Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
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 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99609This product is part of a recall event; the main page for the event is Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
More recalls from Olympus Corporation of the Americas
All 420| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled | Olympus Corporation of the Americas | Labeling Errors | Nationwide |
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