CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Injection needle, bayonet, Luer-Lock recalled by Spiggle & Theis Mt
Spiggle & Theis Mt is recalling Injection needle, bayonet, Luer-Lock, distributed nationwide in the US. The recall was initiated on 27 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2331-2025
- FDA event ID
- 97229
- Recalling firm
- Spiggle & Theis Mt, Dieburg, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2025
- FDA classified
- 15 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 27 Jun 2025 | Recall initiated by company | |
| 15 Aug 2025 | Classified by FDA | +49 days |
| 27 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
Questions about this recall
Why was it recalled?
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Syringes & Needles recalls
All 1,066| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Embosphere 500-700 micrometer Syringe Sterile Steam recalled | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |