Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025,... — FDA record Z-3074-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
Reason
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.
Classification
Class II
Recalling firm
Sol-Millennium Medical Inc.
Quantity
Not supplied
Agency-reported status
Ongoing
Source record identifier
Z-3074-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitySyringes 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

Match all identifying details in the current notice. A brand name alone is not enough.

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 18, 2024
Recall initiation date
May 9, 2024
Center classification date
Sep 6, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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