Reported Sep 18, 2024 · Ongoing

Syringes with Fixed Needles 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 Fixed Needles labeled as

53 of 53 products

Products covered by this recall
Model / numberProduct as published
SOL-M
818392014884SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, , Lot Numbers: 4302039, 4308074
818392011593SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, , Lot Numbers: 4103001, 4106151, 4111045, 4304001
818392011609SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, , Lot Numbers: 4103001, 4106151, 4111045, 4304001
818392011616SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, , Lot Numbers: 4103001, 4106151, 4111045, 4304001
SOL-CARE
810018098148SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1'', Model No. 12310SN, , Lot Numbers: 4108032, 7107049
810018098827SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1 1/2'', Model No. 12315SN, , Lot Numbers: 4110077
810018098155SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 12515SN, , Lot Numbers: 4108033, 7107048
810018098162SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 32515SN, , Lot Numbers: 4108034, 4109052
MEDLINE
10888277222298MEDLINE 1ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS101235F, , Lot Numbers: 1008006, 1011003, 1011012, 1103028, 1105073, 1909004, 1910005, 1910037, 1911016, 19061701
10888277222472MEDLINE 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS101255F, , Lot Numbers: 1009007, 1009014, 1011013, 1011023, 1102018, 1105074, 1910038, 1911017, 1912007
10888277222489MEDLINE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. SYRS101272F, , Lot Numbers: 1001014, 1001016, 1009006, 1010004, 1012006, 19041693, 19052315, 19061702, 19071701
10888277222502MEDLINE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. SYRS101392F, , Lot Numbers: 1009041, 1103029, 1109049, 1110059, 1111051
10888277222519MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. SYRS103205, , Lot Numbers: 1003008, 1009015, 1011014, 1011024, 1012010, 1912008, 19041694
10888277222526MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS103207, , Lot Numbers: 1102013, 1103030, 1105052
10888277222533MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1, Model No. SYRS103215, , Lot Numbers: 1007004, 1012007, 1101011, 1102019, 1104037, 1909007, 1910033, 1912009, 19040902
10888277222540MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS103217, , Lot Numbers: 1001020, 1010005, 1012008, 1104038, 1912010, 19072630
10888277222557MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. SYRS103225, , Lot Numbers: 1008007, 1009004, 1010002, 1012004, 1101010, 1102014, 1104039, 1105053, 1105075, 1909005, 1910006, 1910034, 1910039, 1911018, 19071702

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.