Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Injection needle Recalled by Spiggle & Theis Mt Gmbh Due to Affected product show elevated cytotoxicity values. Use of...

Date: June 27, 2025
Company: Spiggle & Theis Mt Gmbh
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spiggle & Theis Mt Gmbh directly.

Affected Products

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

Quantity: N/A

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Spiggle & Theis Mt Gmbh

Spiggle & Theis Mt Gmbh has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report