CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Syringes with Fixed Needles labeled as: a) Sol recalled
Sol-Millennium Medical is recalling Syringes with Fixed Needles labeled as: a) Sol-m: Sol-m TB Syringe w/Fixed Needle*5/8'', 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
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-3074-2024
- 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 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;
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
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?
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
Where was it sold?
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
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 94968This 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 |
|---|---|---|---|---|---|
| CLASS II | Syringes with Eccentric Tips labeled as recalled | Sol-Millennium Medical | Other | Nationwide | |
| CLASS II | Syringes with Luer Slip Tips labeled as recalled | Sol-Millennium Medical | Other | Nationwide | |
| CLASS II | Syringes with Low Dead Space labeled as recalled | Sol-Millennium Medical | Other | Nationwide | |
| CLASS II | Syringes with exchangeable needles labeled as: Sol-care recalled | Sol-Millennium Medical | Other | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Syringe Tip Caps labeled as: Sol-m Syringe Tip Cap, Blue recalled | Sol-Millennium Medical | Other | Nationwide |
| Device | CLASS II | Syringes with exchangeable needles labeled as: Sol-care recalled | Sol-Millennium Medical | Other | Nationwide |
| Device | CLASS II | Syringes with Low Dead Space labeled as recalled | Sol-Millennium Medical | Other | Nationwide |
| Device | CLASS II | Syringes with Luer Slip Tips labeled as recalled | Sol-Millennium Medical | Other | Nationwide |
| Device | CLASS II | Syringes with Eccentric Tips labeled as recalled | Sol-Millennium Medical | Other | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |