# FDA recall Z-3076-2024

> **Sol-Millennium Medical Inc.** · Class II · device recall initiated 2024-05-09.

## Product

Syringes with Luer Slip Tips labeled as:    1)	SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138;   2)	SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523;   3)	SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998;   4)	SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493;   5)	SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462;   6)	SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646;   7)	SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636;   8)	SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333;   9)	SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340;   10)	SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

## Reason for recall

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

## Distribution

US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama

## Key facts

- **Recall number:** Z-3076-2024
- **Recalling firm:** Sol-Millennium Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-09
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3076-2024

## Citation

> AI Analytics. FDA recall Z-3076-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-3076-2024. Source: US FDA. Licensed CC0.

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