Recall Z-2331-2025— Spiggle & Theis Mt Gmbh
Class II · Ongoing
Class II FDA medical device recall by Spiggle & Theis Mt Gmbh, initiated 2025-06-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction..
- Recalling firm
- Spiggle & Theis Mt Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-27
- Firm location
- Dieburg, N/A, Germany
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
Reason for recall
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.