Injection needle, bayonet, Luer-Lock recallZ-2331-2025 · Spiggle & Theis Mt Gmbh · initiated Jun 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spiggle & Theis Mt Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2331-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 27, 2025
- Posted by the FDA
- Aug 15, 2025
- Recalling firm
- Spiggle & Theis Mt Gmbh
- Product code
- GDM
- Distribution
- US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
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
Code information (models, lots, serial 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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Injection needle 50-353-23Spiggle & Theis Medizintechnik GmbH · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 recall0 reports
- Injection needle 50-345-23Spiggle & Theis Medizintechnik GmbH · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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