Sol-Millennium Medical Inc. Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 81 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
Product
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 81
Brand
Sol-Millennium Medical Inc.
Lot Codes / Batch Numbers
a) SOL-M: 1) Model No. 1812010, UPC 818392010268, Lot Numbers: 4202007, 2) Model No. 1812015, UPC 818392010275, Lot Numbers: 4110010, 3) Model No. 1812110, UPC 818392010244, Lot Numbers: 4202008, 4) Model No. 1812115, UPC 818392010251, Lot Numbers: 2108094, 4110087, 4110088, 4303013, 4303015, 4304027, 4311001, 4312014, 4312022, 5) Model No. 1812210, UPC 818392010237, Lot Numbers: 4302040, 6) Model No. 1832010, UPC 818392011586, Lot Numbers: 4110005, 7) Model No. 1832015, UPC 818392010114, Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021, 4110005, 8) Model No. 1832110, UPC 818392010084, Lot Numbers: 5105119, 19041740, 9) Model No. 1832115, UPC 818392010091, Lot Numbers: 4106053, 4202035, 4306035, 10) Model No. 1832210, UPC 818392010039, Lot Numbers: 4110006, 4209012, 11) Model No. 1832215, UPC 818392010077, Lot Numbers: 4102053, 4106153, 4202003, 4202003, 4306034, 4307015, 4307043, 4308047, 4309030, 4309040, 4310033, 12) Model No. 1832310, UPC 818392010107, Lot Numbers: 4102058, 4102059, 4103020, 4103021, 4103028, 4103029, 4106048, 4106049, 4106052, 4110007, 4110053, 1902183, 19021824, 13) Model No. 1832510, UPC 818392010053, Lot Numbers: 4012001, 4102056, 4103014, 4103015, 4103022, 4103023, 4103030, 4103031, 4106050, 4106051, 4109091, 19021825, 19021826, 19041742, 14) Model No. 1832515, UPC 818392010046, Lot Numbers: 4012002, 4102054, 4103018, 4103019, 15) Model No. 1832558, UPC 818392010022, Lot Numbers: 4007045, 40 10033, 4102050, 4102051, 4102052, 4103016, 4103017, 4110011, 4110012, 16) Model No. 1852010, UPC 818392010190, Lot Numbers: EXPIRED 17) Model No. 1852015, UPC 818392010206, Lot Numbers: EXPIRED 18) Model No. 1852115, UPC 818392010183, Lot Numbers: 4103076, 4105110, 19) Model No. 1852215, UPC 818392010169, Lot Numbers: 4001001, 4003019, 4110083, 4110084, 4202004, 4308046, 4308088, 4312097, 19052010, 20) Model No. 110101120011, UPC 818392014341, Lot Numbers: 4212007, 4306027, 4308066, 19030602, 21) Model No. 110101120012, UPC 818392014358, Lot Numbers: 4001021, 4008151, 4104087, 4110036, 4202006, 19030603, 22) Model No. 1832110T, UPC 818392012880, Lot Numbers: 4103002, 4104043, 4105120, 4106152, 4109083, 4110045, 4111040, 4206041, 4206042, 4206043, 4208008, 4208009, 4208010, 4303041, 4304026, 4306046, 4308071, 4312018, 23) Model No. 1832210T, UPC 818392013061, Lot Numbers: 4110046, 4307048, 4308091, 24) Model No. 1832310T, UPC 10818392013075, Lot Numbers: 4110047, 25) Model No. 1852010T, UPC 818392013702, Lot Numbers: 4104083, 26) Model No. 1852110T, UPC 818392013696, Lot Numbers: 4005030, 4007049, 4103080, 4104084, 4105111, 4302024, 4308067, 4310031, 4312019, 4312102, 4912026, 19072314, b) SOL-CARE: 1) Model No. 102115SN, UPC 818392019858, Lot Numbers: 4104022, 2) Model No. 102215SN, UPC 818392019865, Lot Numbers: 4004004, 4303018, 4304057, 3) Model No. 12510SN, UPC 818392018851, Lot Numbers: 4108037, 7106031, 7109036, 4) Model No. 12558SN, UPC 818392018950, Lot Numbers: 4004005, 4104008, 4104011, 4104012, 4106034, 7107051, 7112016, 5) Model No. 12705SN, UPC 818392018967, Lot Numbers: 4004006, 7109007, 6) Model No. 13005SN, UPC 818392018974, Lot Numbers: 4004002, 7) Model No. 32110SN, UPC 818392019001, Lot Numbers: 4004031, 5101401, 8) Model No. 32115SN, UPC 818392019018, Lot Numbers: 4109051, 19072315, 9) Model No. 32210SN, UPC 818392019025, Lot Numbers: 4007046, 4301035, 4312117, 10) Model No. 32215SN, UPC 818392019032, Lot Numbers: 4301036, 11) Model No. 32310SN, UPC 818392019049, Lot Numbers: 3102005, 4004031, 4104013, 4107091, 4108035, 5104011, 5104012, 12) Model No. 32510SN, UPC 818392019063, Lot Numbers: 4007047, 4007051, 4104009, 4105096, 4105100, 4108031, 4108032, 4108036, 7111006, 13) Model No. 32558SN, UPC 818392019070, Lot Numbers: 4007048, 4007052, 4104010, 4104018, 14) Model No. 52115SN, UPC 818392018912, Lot Numbers: 4110017, 4309051, 15) Model No. 52215SN, UPC 818392018936, Lot Numbers: 4004003, 4107173, c) HENRY SCHEIN: 1) Model No. 900-7842, UPC 10304040017200, Lot Numbers: 1012089, 1012091, 1102061, 1103043, 1103044, 1103045, 1103046, 2111063, 2111064, 2203033, 2209013, 2211025, 2211026, 2307003, 2307094, 2309046, 4005032, 4005054, 4007040, 4007041, 2) Model No. 900-7843, UPC 10304040017217, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007, 3) Model No. 900-7844, UPC 10304040017224, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007
Products Sold
a) SOL-M: 1) Model No. 1812010, UPC 818392010268, Lot Numbers: 4202007; 2) Model No. 1812015, UPC 818392010275, Lot Numbers: 4110010; 3) Model No. 1812110, UPC 818392010244, Lot Numbers: 4202008; 4) Model No. 1812115, UPC 818392010251, Lot Numbers: 2108094, 4110087, 4110088, 4303013, 4303015, 4304027, 4311001, 4312014, 4312022; 5) Model No. 1812210, UPC 818392010237, Lot Numbers: 4302040; 6) Model No. 1832010, UPC 818392011586, Lot Numbers: 4110005; 7) Model No. 1832015, UPC 818392010114, Lot Numbers: 1010016, 1012011, 1012019, 1110067, 1112021, 1112056, 1301021, 4110005; 8) Model No. 1832110, UPC 818392010084, Lot Numbers: 5105119, 19041740; 9) Model No. 1832115, UPC 818392010091, Lot Numbers: 4106053, 4202035, 4306035; 10) Model No. 1832210, UPC 818392010039, Lot Numbers: 4110006, 4209012; 11) Model No. 1832215, UPC 818392010077, Lot Numbers: 4102053, 4106153, 4202003, 4202003, 4306034, 4307015, 4307043, 4308047, 4309030, 4309040, 4310033; 12) Model No. 1832310, UPC 818392010107, Lot Numbers: 4102058, 4102059, 4103020, 4103021, 4103028, 4103029, 4106048, 4106049, 4106052, 4110007, 4110053, 1902183, 19021824; 13) Model No. 1832510, UPC 818392010053, Lot Numbers: 4012001, 4102056, 4103014, 4103015, 4103022, 4103023, 4103030, 4103031, 4106050, 4106051, 4109091, 19021825, 19021826, 19041742; 14) Model No. 1832515, UPC 818392010046, Lot Numbers: 4012002, 4102054, 4103018, 4103019; 15) Model No. 1832558, UPC 818392010022, Lot Numbers: 4007045, 40 10033, 4102050, 4102051, 4102052, 4103016, 4103017, 4110011, 4110012; 16) Model No. 1852010, UPC 818392010190, Lot Numbers: EXPIRED 17) Model No. 1852015, UPC 818392010206, Lot Numbers: EXPIRED 18) Model No. 1852115, UPC 818392010183, Lot Numbers: 4103076, 4105110; 19) Model No. 1852215, UPC 818392010169, Lot Numbers: 4001001, 4003019, 4110083, 4110084, 4202004, 4308046, 4308088, 4312097, 19052010; 20) Model No. 110101120011, UPC 818392014341, Lot Numbers: 4212007, 4306027, 4308066, 19030602; 21) Model No. 110101120012, UPC 818392014358, Lot Numbers: 4001021, 4008151, 4104087, 4110036, 4202006, 19030603; 22) Model No. 1832110T, UPC 818392012880, Lot Numbers: 4103002, 4104043, 4105120, 4106152, 4109083, 4110045, 4111040, 4206041, 4206042, 4206043, 4208008, 4208009, 4208010, 4303041, 4304026, 4306046, 4308071, 4312018; 23) Model No. 1832210T, UPC 818392013061, Lot Numbers: 4110046, 4307048, 4308091; 24) Model No. 1832310T, UPC 10818392013075, Lot Numbers: 4110047; 25) Model No. 1852010T, UPC 818392013702, Lot Numbers: 4104083; 26) Model No. 1852110T, UPC 818392013696, Lot Numbers: 4005030, 4007049, 4103080, 4104084, 4105111, 4302024, 4308067, 4310031, 4312019, 4312102, 4912026, 19072314; b) SOL-CARE: 1) Model No. 102115SN, UPC 818392019858, Lot Numbers: 4104022; 2) Model No. 102215SN, UPC 818392019865, Lot Numbers: 4004004, 4303018, 4304057; 3) Model No. 12510SN, UPC 818392018851, Lot Numbers: 4108037, 7106031, 7109036; 4) Model No. 12558SN, UPC 818392018950, Lot Numbers: 4004005, 4104008, 4104011, 4104012, 4106034, 7107051, 7112016; 5) Model No. 12705SN, UPC 818392018967, Lot Numbers: 4004006, 7109007; 6) Model No. 13005SN, UPC 818392018974, Lot Numbers: 4004002; 7) Model No. 32110SN, UPC 818392019001, Lot Numbers: 4004031, 5101401; 8) Model No. 32115SN, UPC 818392019018, Lot Numbers: 4109051, 19072315; 9) Model No. 32210SN, UPC 818392019025, Lot Numbers: 4007046, 4301035, 4312117; 10) Model No. 32215SN, UPC 818392019032, Lot Numbers: 4301036; 11) Model No. 32310SN, UPC 818392019049, Lot Numbers: 3102005, 4004031, 4104013, 4107091, 4108035, 5104011, 5104012; 12) Model No. 32510SN, UPC 818392019063, Lot Numbers: 4007047, 4007051, 4104009, 4105096, 4105100, 4108031, 4108032, 4108036, 7111006; 13) Model No. 32558SN, UPC 818392019070, Lot Numbers: 4007048, 4007052, 4104010, 4104018; 14) Model No. 52115SN, UPC 818392018912, Lot Numbers: 4110017, 4309051; 15) Model No. 52215SN, UPC 818392018936, Lot Numbers: 4004003, 4107173; c) HENRY SCHEIN: 1) Model No. 900-7842, UPC 10304040017200, Lot Numbers: 1012089, 1012091, 1102061, 1103043, 1103044, 1103045, 1103046, 2111063, 2111064, 2203033, 2209013, 2211025, 2211026, 2307003, 2307094, 2309046, 4005032, 4005054, 4007040, 4007041; 2) Model No. 900-7843, UPC 10304040017217, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007; 3) Model No. 900-7844, UPC 10304040017224, Lot Numbers: 1012090, 1102062, 1103053, 2211027, 2303042, 2307005, 4003020, 4004038, 4007042, 4109001, 4109002, 4910032, 4911007
Sol-Millennium Medical Inc. is recalling Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/S due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Sol M issued a Voluntary Recall Action Letter to Distributors to its consignees on 05/09/2024 via email. The notice explained the reason for the recall and requested the following: "ACTIONS REQUIRED: 1. Examine your inventory and quarantine the affected product codes and lots subject to this recall action. 2. Distributors, please identify your customers, and notify them at once of this recall action to the distributor level. Such notification may be enhanced by including the enclosed letter (Appendix B) for your customers and Healthcare Providers (HCP s) in the field. 3. Return the enclosed Appendix B with the information via email to recalls@sol-m.com. The quarantine should be carried out to the wholesale and distributor level. Products in the field beyond the control of the distributor or wholesaler should be recalled from the field and returned to the distributor. Distributors should quarantine the products in inventory and quarantine the products received from customers until the 510(k) submissions are pending or cleared. The returned product should be quarantined in a secure location to avoid distribution based on your quality management procedures. We will provide communication with any updates as we work with the FDA."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026