CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report

Syringes with Luer Slip Tips labeled as recalled

Sol-Millennium Medical is recalling Syringes with Luer Slip Tips labeled as: Sol-m Slip Tip Syringe w/o Needle, distributed nationwide in the US. The recall was initiated on 9 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Model No. 180011, UPC 8183923010138, Lot Numbers: 19072506; 2) Model No. P180011, UPC 810018097523, Lot Numbers: 4107175, 4107176, 4110015, 4312056; 3) Model No. 180020ST, UPC 840368511998, Lot Numbers: 4209011; 4) Model No. P180003ST, UPC 810018097493, Lot Numbers: 4105121; 5) Model No. P180005ST, UPC 810018097462, Lot Numbers: 4104054; 6) Model No. P180010ST, UPC 810018097646, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050; 7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048; 8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041; 9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042; 10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002

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-3076-2024
FDA event ID: 94968
Recalling firm: Sol-Millennium Medical, Chicago, IL
Classification: Class II
Status: Ongoing
Recall initiated: 9 May 2024
FDA classified: 6 Sep 2024
Reported: 18 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

9 May 2024	Recall initiated by company
6 Sep 2024	Classified by FDA	+120 days
18 Sep 2024	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

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

1) Model No. 180011, UPC 8183923010138, Lot Numbers: 19072506; 2) Model No. P180011, UPC 810018097523, Lot Numbers: 4107175, 4107176, 4110015, 4312056; 3) Model No. 180020ST, UPC 840368511998, Lot Numbers: 4209011; 4) Model No. P180003ST, UPC 810018097493, Lot Numbers: 4105121; 5) Model No. P180005ST, UPC 810018097462, Lot Numbers: 4104054; 6) Model No. P180010ST, UPC 810018097646, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050; 7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048; 8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041; 9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042; 10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002

Where was it sold?

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 products in this recall event

5 other products · FDA event 94968

This product is part of a recall event; the main page for the event is Syringes with Eccentric Tips labeled as recalled.

Reported	Class	Recall	Company	Reason	Where
18 Sep 2024	CLASS II	Syringes with Eccentric Tips labeled as recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024	CLASS II	Syringes with Low Dead Space labeled as recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024	CLASS II	Syringes with exchangeable needles labeled as: Sol-care recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024	CLASS II	Syringes with Fixed Needles labeled as: a) Sol recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024	CLASS II	Syringe Tip Caps labeled as: Sol-m Syringe Tip Cap, Blue recalled	Sol-Millennium Medical	Other	Nationwide

More recalls from Sol-Millennium Medical

All 6

Reported	Class	Recall	Company	Reason	Where
18 Sep 2024Device	CLASS II	Syringe Tip Caps labeled as: Sol-m Syringe Tip Cap, Blue recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024Device	CLASS II	Syringes with Fixed Needles labeled as: a) Sol recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024Device	CLASS II	Syringes with exchangeable needles labeled as: Sol-care recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024Device	CLASS II	Syringes with Low Dead Space labeled as recalled	Sol-Millennium Medical	Other	Nationwide
18 Sep 2024Device	CLASS II	Syringes with Eccentric Tips labeled as recalled	Sol-Millennium Medical	Other	Nationwide

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All 1,060

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