FDA Medical devices recall ·
Injection needle, bayonet, Luer-Lock, 1. Model no recall
- Recall number
- Z-2331-2025
- Date
- (initiated June 27, 2025)
- Company / brand
- Spiggle & Theis Mt Gmbh
Lagerstr. 11, Dieburg, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. Model No 50-353-23; UDI-DI 04250381858806; LOT (0)2241239 2. Model No 50-345-23; UDI-DI 04250381858813; LOT 2230438; LOT 2240251
Distribution
US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
States: California Connecticut Missouri Ohio
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2331-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.