# Class I recall Z-3252-2026: Draeger, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 76/100

| 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 |

## Why this score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3252-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.