Class I recall Z-3252-2026: Draeger, Inc.
Class I recall Z-3252-2026: Draeger, Inc. (Pennsylvania): Draeger, Inc. Dated 28 days ago, it is in the active follow-up window. 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: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3252-2026 |
| Recalling firm | Draeger, Inc. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module. |
| Reason | Potential cracks in the hose, which could lead to leakage or the hose falling off. |
| Quantity | 1,063,643 units |
| Distribution | US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Ki |
| Recall initiated | 2026-09-03 |
| Reported | 2026-10-07 |
| Firm location | Telford, 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: 2026-10-07
- 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-3252-2026: Draeger, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (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 28 days ago.
What is the FDAPulse record for Class I recall Z-3252-2026: Draeger, Inc. in Pennsylvania?
Class I device recall Z-3252-2026 by Draeger, Inc.: Potential cracks in the hose, which could lead to leakage or the hose falling off.
How does Class I recall Z-3252-2026: Draeger, Inc. compare to other Pennsylvania FDAPulse records?
It is 28 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-3252-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class I recall Z-3252-2026 | PA | 2026-10-07 |
| 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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