Injection Needle (Spiggle & Theis) – Cytotoxicity Risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany
Lot Codes / Batch Numbers
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
Products Sold
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
Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany is recalling Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length due to Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026