Class I recall Z-3140-2026: CooperSurgical, Inc.
Class I recall Z-3140-2026: CooperSurgical, Inc. (Connecticut): CooperSurgical, Inc. Dated 36 days ago, it serves as a historical benchmark. Score 76/100. As of 2026-11-04, 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: 1 related CT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3140-2026 |
| Recalling firm | CooperSurgical, Inc. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. |
| Reason | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored. |
| Quantity | 149 boxes (745 units) |
| Distribution | Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru. |
| Recall initiated | 2026-08-11 |
| Reported | 2026-09-30 |
| Firm location | Trumbull, CT, United States |
| Peer records CSV (2 CT 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: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class I recall Z-3140-2026: CooperSurgical, Inc. and 2 Connecticut peers
- Connecticut FDAPulse records like this one: 2
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Connecticut peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
76 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 36 days ago.
What is the FDAPulse record for Class I recall Z-3140-2026: CooperSurgical, Inc. in Connecticut?
Class I device recall Z-3140-2026 by CooperSurgical, Inc.: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in u
How does Class I recall Z-3140-2026: CooperSurgical, Inc. compare to other Connecticut FDAPulse records?
It is 36 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 76/100 puts it among the stronger signals in this feed.
Class I recall Z-3140-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class I recall Z-3140-2026 | CT | 2026-09-30 |
| Class I recall Z-0127-2027 | WA | 2026-10-28 |
| Class I recall Z-0132-2027 | WA | 2026-10-28 |
| Class I recall Z-0131-2027 | WA | 2026-10-28 |
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