Class II FDA device recall · Z-3074-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G1 1/2'', Model No. 1811815B, UPC 818392011616;

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Syringes with Fixed Needles labeled as:   a) SOL-M:  1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884, Lot Numbers:  4302039, 4308074;   2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593, Lot Numbers:  4103001, 4106151, 4111045, 4304001;   3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609, Lot Numbers:  4103001, 4106151, 4111045, 4304001;   4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616, Lot Numbers:  4103001, 4106151, 4111045, 4304001;  b) SOL-CARE:    1) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1'', Model No. 12310SN, UPC 810018098148, Lot Numbers:  4108032, 7107049;    2) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1 1/2'', Model No. 12315SN, UPC 810018098827, Lot Numbers:  4110077;   3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 12515SN, UPC 810018098155, Lot Numbers:  4108033, 7107048;   4) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2'', Model No. 32515SN, UPC 810018098162, Lot Numbers:  4108034, 4109052; c) MEDLINE:  1) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS101235F, UPC 10888277222298, Lot Numbers:  1008006, 1011003, 1011012, 1103028, 1105073, 1909004, 1910005, 1910037, 1911016, 19061701;   2) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS101255F, UPC 10888277222472, Lot Numbers:  1009007, 1009014, 1011013, 1011023, 1102018, 1105074, 1910038, 1911017, 1912007;   3) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. SYRS101272F, UPC 10888277222489, Lot Numbers:  1001014, 1001016, 1009006, 1010004, 1012006, 19041693, 19052315, 19061702, 19071701;   4) MEDLINE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. SYRS101392F, UPC 10888277222502, Lot Numbers:  1009041, 1103029, 1109049, 1110059, 1111051;   5) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. SYRS103205, UPC 10888277222519, Lot Numbers:  1003008, 1009015, 1011014, 1011024, 1012010, 1912008, 19041694;   6) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS103207, UPC 10888277222526, Lot Numbers:  1102013, 1103030, 1105052;   7) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1, Model No. SYRS103215, UPC 10888277222533, Lot Numbers:  1007004, 1012007, 1101011, 1102019, 1104037, 1909007, 1910033, 1912009, 19040902;   8) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS103217, UPC 10888277222540, Lot Numbers:  1001020, 1010005, 1012008, 1104038, 1912010, 19072630;   9) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. SYRS103225, UPC 10888277222557, Lot Numbers:  1008007, 1009004, 1010002, 1012004, 1101010, 1102014, 1104039, 1105053, 1105075, 1909005, 1910006, 1910034, 1910039, 1911018, 19071702;   10) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS103227, UPC 10888277222564, Lot Numbers:  1001017, 1004041, 1009005, 1009016, 1010003, 1011015, 1011025, 1012005, 1102015, 1102020, 1909008, 1910035, 1910040, 1911019, 19040901;   11) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. SYRS103235, UPC 10888277222571, Lot Numbers:  1004040, 1006027, 1007001, 1007005, 1008020, 1008022, 1009001, 1010001, 1011005, 1011016, 1011026, 1011026, 1012001, 1102011, 1102016, 1102021, 1103024, 1105045, 1105054, 1105076, 1911020, 1912011, 19040903, 19052316, 19071703, 19072631;   12) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. SYRS103253, UPC 10888277222588, Lot Numbers:  1007002, 1007006, 1009002, 1012002, 1101009, 1102022, 1103031, 1104040, 1105055, 1105077, 1911021, 19052317, 19072632;   13) MEDLINE 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. SYRS103255, UPC 10888277222595, Lot Numbers:  1007007, 1008008, 1008021, 1008023, 1009003, 1010001, 1011006, 1011017, 1011027, 1012003, 1101006, 1102012, 1102017, 1102023, 1103023, 1910007, 1910036, 1911022, 19072633;   14) MEDLINE 5ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS105217, UPC 10888277222632, Lot Numbers:  1003009, 1011004, 1101008, 1910041, 19041695;   15) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. SYRS110207, UPC 10888277222670, Lot Numbers:  1009017, 1101007;   16) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. SYRS110217, UPC 10888277222694, Lot Numbers:  1003010, 1012009, 1104041, 19051518, 19072640;   17) MEDLINE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. SYRS110227, UPC 10888277222892, Lot Numbers:  1001019, 1105078, 1909006, 1910042, 19072635;  d) MONOJECT:   1)  MONOJECT 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11812558, UPC 1092253025132, Lot Numbers:  1004002, 1004039, 1006001, 1012017, 1102039, 1103012, 1104002, 1107027, 1108027, 1108031, 1108046, 1205005, 1210005, 1301022, 1308036, 1310021, 1312020;   2) MONOJECT 1ml Syringe w/Hypodermic Safety Needle 27G*1/2, Model No. 11812705, UPC 10192253025149, Lot Numbers: 1008024, 1012018, 1103013, 1104003, 1104016, 1107028, 1108028, 1108032, 1108051, 1910016;    3) MONOJECT 1ml Luer Lock Syringe w/Safety Needle 30G*1/2, Model No. 11813005, UPC 10192253025156, Lot Numbers:  1012024, 1211001;   4) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1, Model No. 11832010, UPC 10192253025163, Lot Numbers:  1107029, 1108047;   5) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 20G*1 1/2, Model No. 11832015, UPC 10192253025170, Lot Numbers:  1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021;   6) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 21G*1, Model No. 11832110, UPC 10192253025187, Lot Numbers:  1108033, 1108048, 1110066, 1111052, 1112020, 1112055, 1910017;   7) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 11832115, UPC 10192253025194, Lot Numbers:  1107030, 1108029, 1108034, 1108049, 1304019, 1305008, 1310004;   8) MONOJECT 3ml Syringe w/Hypodermic Safety Needle 22G*1, Model No. 11832210, UPC 10192253025200, Lot Numbers:  1010017, 1012012, 1012020, 1110068, 1112022, 1201008, 1203020, 1302007, 1304018, 1305009, 1312021, 1910018;   9) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 11832215, UPC 10192253025217, Lot Numbers:  1010018, 1012013, 1012021, 1102036, 1107031, 1305010, 1306008, 1310005, 1312022;   10) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 11832310, UPC 10192253025224, Lot Numbers:  1006002, 1010007, 1010009, 1010019, 1011007, 1011008, 1011009, 1011010, 1011011, 1012014, 1012022, 1102037, 1103011, 1104001, 1104017, 1104018, 1104019, 1104020, 1104021, 1108034, 1910019;   11) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 23G*1 1/2, Model No. 11832315, UPC 10192253025231, Lot Numbers:  1010020, 1012015, 1012023, 1102038, 1104022, 1105001;   12) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 11832510, UPC 10192253025248, Lot Numbers:  1012016, 1102040, 1103014, 1104004, 1105002, 1105003, 1108030, 1108050, 1910020;   13) MONOJECT 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 11832558, UPC 10192253025225, Lot Numbers:  1012025, 1102041, 1103015, 1104005, 1105004, 1107032, 1108036, 1108052;  e) HENRY SCHEIN:    1) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2, Model No. 900-7640, UPC 10304040017057, Lot Numbers:  1003005, 1011037, 1102053, 1106079, 1307004, 1910010, 1911033;   2) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1, Model No. 900-7641, UPC 10304040017064, Lot Numbers:  1003007, 1011038, 1101004, 1102054, 1110060, 1211003, 1303004, 1307006, 1910008, 1911034;   3) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2, Model No. 900-7642, UPC 10304040017071, Lot Numbers:  110608, 1003006, 1011039, 1101005, 1106080, 1303003, 1304013, 1307007, 1910011, 1911035, 19042613;   4) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 23G*1, Model No. 900-7643, UPC 10304040017088, Lot Numbers:  1001003, 1009036, 1011040, 1012042, 1103022, 1106081, 1108057, 1112054, 1203021, 1307005, 1910009, 1911003, 1912001, 19042614, 19072303;   5) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7644, UPC 10304040017095, Lot Numbers:  191008, 1006016, 1009037, 1010006, 1011054, 1011062, 1104061, 1104063, 1105025, 1105027, 1105029, 1105031, 1105033, 1105035, 1105037, 1106082, 1108056, 1911008, 1911030;   6) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7645, UPC 10304040017101, Lot Numbers:  1008011, 1009035, 1012043, 1102051, 1106077, 1112053, 1202007, 1203015, 1911009, 1911036, 1912014, 19072304;   7) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*5/8, Model No. 900-7646, UPC 10304040017118, Lot Numbers:  1001021, 1008012, 1009039, 1101003, 1102056, 1104062, 1104064, 1105026, 1105028, 1105030, 1105032, 1105034, 1105036, 1105038, 1106084, 1309012, 1911032, 19042616;   8) HENRY SCHEIN 3ml Luer Lock Syringe w/Safety Needle 25G*1 1/2, Model No. 900-7647, UPC 10304040017125, Lot Numbers:  1004001, 1102055, 1106083, 1911028;   9) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 27G*1/2, Model No. 900-7648, UPC 10304040017149, Lot Numbers:  1009034, 1102052, 1106078, 1109046, 1211004, 1908010, 1911010, 1911029, 19042615;   10) HENRY SCHEIN 1ml Luer Lock Syringe w/Safety Needle 25G*1, Model No. 900-7663, UPC 10304040017194, Lot Numbers:  1001008, 1011041, 1102050, 1106076, 1911004

Recall status

Ongoing — the recall is still being carried out.

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

Recall record

Recalling firm: Sol-Millennium Medical Inc.
Product type: Devices
Recall number: Z-3074-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Chicago, IL
Recall initiated: 2024-05-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-3074-2024 · Source: openFDA enforcement.