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
Reported: August 27, 2025 Initiated: June 27, 2025 #Z-2331-2025
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
Reason for Recall
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Details
- Recalling Firm
- Spiggle & Theis Mt Gmbh
- Units Affected
- N/A
- Distribution
- US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
- Location
- Dieburg, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Spiggle & Theis Mt Gmbh. Units affected: N/A.
Why was this product recalled? ▼
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2025. Severity: Moderate. Recall number: Z-2331-2025.
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