# Class II recall Z-0140-2027: Becton Dickinson & Co.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0140-2027 |
| Recalling firm | Becton Dickinson & Co. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | BD Phoenix Panel NMIC-306. Catalog Number: 449292. |
| Reason | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| Quantity | 669,200 units |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-08-13 |
| Reported | 2026-10-21 |
| Firm location | Sparks, MD, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 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-0140-2027%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.