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Open, Classified

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

FDA Recall Z-2331-2025 · Posted 2025-08-15

Recalling FirmSpiggle & Theis Mt Gmbh
Recall StatusOpen, Classified
Product CodeGDM
Date Initiated2025-06-27

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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