Spiggle & Theis Mt Gmbh: Device Recall
Recall #Z-2331-2025 · 06/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2331-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spiggle & Theis Mt Gmbh
- Status
- Ongoing
- Date Initiated
- 06/27/2025
- Location
- Dieburg, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Reason for Recall
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.