Reported Sep 18, 2024 · Ongoing

Syringes with Eccentric Tips labeled as

Sol-Millennium Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sol-Millennium Medical Inc. · 311 S Wacker Dr · Chicago, IL · 60606-6604

Is this the product you have?

Syringes with Eccentric Tips labeled as

3 of 3 products

Products covered by this recall
Model / numberProduct as published
81001809551SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET
810018098605SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET
810018098698SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET
Lot codes and dates
  • 1) Model No. P180010ET
  • Lot Numbers
    • 4209010
    • 2) Model No. P180020ET
  • Lot Numbers
    • 4209011
    • 3) Model No. P180060ET
  • Lot Numbers
    • 4209009
    • 4209011

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.