Class II recall Z-3247-2026: Olympus Corporation of the Americas
Class II recall Z-3247-2026: Olympus Corporation of the Americas (Pennsylvania): Olympus Corporation of the Americas. Dated 35 days ago, it serves as a historical benchmark. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3247-2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. |
| Reason | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Quantity | 816 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. |
| Recall initiated | 2026-08-19 |
| Reported | 2026-09-30 |
| Firm location | Center Valley, PA, United States |
| Peer records CSV (19 PA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-3247-2026: Olympus Corporation of the Americas and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 35 days ago.
What is the FDAPulse record for Class II recall Z-3247-2026: Olympus Corporation of the Americas in Pennsylvania?
Class II device recall Z-3247-2026 by Olympus Corporation of the Americas: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
How does Class II recall Z-3247-2026: Olympus Corporation of the Americas compare to other Pennsylvania FDAPulse records?
It is 35 days old, still within a typical 45-day follow-up window.
Class II recall Z-3247-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3247-2026 | PA | 2026-09-30 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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