Dieburg, N/A, Germany
Spiggle & Theis Mt Gmbh recalls
1 recall recorded since 2018, most recently on 27 June 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 June 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2331-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.