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Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total leng...

FDA Recall #Z-2331-2025 — Class II — June 27, 2025

Recall #Z-2331-2025 Date: June 27, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

Spiggle & Theis Mt Gmbh — Dieburg, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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