Recall Z-2331-2025 ยท GDM Needle, Aspiration And Injection, Reusable
Spiggle & Theis Mt Gmbh
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
| Date | Aug 15, 2025 (initiated Jun 27, 2025) |
| Status | Open, Classified |
| Reason | Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction. |
| Root cause | Under Investigation by 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. |
| Distribution | US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.