Spiggle & Theis Mt Gmbh recalls Injection needle

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2331-2025
• FDA device classification · GDMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spiggle & Theis Mt GmbhSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.