# FDA recall Z-2489-2021

> **M.D.L. S.r.l.** · Class II · device recall initiated 2021-08-05.

## Product

Bone Marrow Transplantation biopsy needle

## Reason for recall

Sterility assurance may be compromised.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2489-2021
- **Recalling firm:** M.D.L. S.r.l.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-05
- **Report date:** 2021-09-29
- **Termination date:** 2026-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Delebio, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2489-2021

## Citation

> AI Analytics. FDA recall Z-2489-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2489-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*