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
This recall is currently active, issued August 15, 2025. It was issued by Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany.
- Recall Initiated
- June 27, 2025
- Posted
- August 15, 2025
- Recall Number
- Z-2331-2025
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
On June 27, 2025, the firm notified customers through a letter titled "Urgent safety information Recall Injection Needle". Customers were asked to identify and quarantine any affected product in stock. Customer service will assist customers in returning product and the firm will issue a credit upon receipt of the affected product.