# FDA recall Z-2331-2025

> **Spiggle & Theis Mt Gmbh** · Class II · device recall initiated 2025-06-27.

## Product

Injection needle, bayonet, Luer-Lock,    1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;    2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

## Reason for recall

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

## Distribution

US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.

## Key facts

- **Recall number:** Z-2331-2025
- **Recalling firm:** Spiggle & Theis Mt Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-27
- **Report date:** 2025-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dieburg, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2025

## Citation

> AI Analytics. FDA recall Z-2331-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2331-2025. Source: US FDA. Licensed CC0.

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