Injection needle recalled over sterility concerns

Recall date

June 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Spiggle & Theis Mt Gmbh recalls Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. M…

Recall number

Z-2331-2025

FDA classification

Class II

Brand / firm

Spiggle & Theis Mt Gmbh

Sold / distributed

US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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