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U.S. Department of Health and Human Services

Class 2 Device Recall injection needle

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 Class 2 Device Recall injection needlesee related information
Date Initiated by FirmJune 27, 2025
Date PostedAugust 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2331-2025
Recall Event ID 97229
Product Classification Needle, aspiration and injection, reusable - Product Code GDM
ProductInjection 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
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
FEI Number 3002858762
Recalling Firm/
Manufacturer		 Spiggle & Theis Mt Gmbh
Lagerstr. 11
Dieburg Germany
Manufacturer Reason
for Recall		Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
DistributionUS Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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