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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94968

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sol-Millennium Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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;

Z-3074-2024
Recall number
Z-3074-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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

device · product 2 of 6

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 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

Z-3075-2024
Recall number
Z-3075-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 3 of 6

Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

Z-3076-2024
Recall number
Z-3076-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Model No. 180011, UPC 8183923010138, Lot Numbers: 19072506; 2) Model No. P180011, UPC 810018097523, Lot Numbers: 4107175, 4107176, 4110015, 4312056; 3) Model No. 180020ST, UPC 840368511998, Lot Numbers: 4209011; 4) Model No. P180003ST, UPC 810018097493, Lot Numbers: 4105121; 5) Model No. P180005ST, UPC 810018097462, Lot Numbers: 4104054; 6) Model No. P180010ST, UPC 810018097646, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050; 7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048; 8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041; 9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042; 10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002

Distribution pattern

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

device · product 4 of 6

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;

Z-3077-2024
Recall number
Z-3077-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Model No. P180010ET, Lot Numbers: 4209010; 2) Model No. P180020ET, Lot Numbers: 4209011; 3) Model No. P180060ET, Lot Numbers: 4209009, 4209011;

Distribution pattern

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

device · product 5 of 6

Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

Z-3078-2024
Recall number
Z-3078-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

a) Model No. 180011LDS, UPC 840368511899, Lot Numbers: 1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401; b) Model No. P180011LDS, UPC 810018097554, Lot Numbers: 4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032; c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers: 4301029; d) Model No. 12558LDS, UPC 810062435319, Lot Numbers: 7210016; e) Model No. P180001PP, UPC 818392018165, Lot Numbers: 4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033; f) Model No. 181025S, UPC NONE, Lot Numbers: 4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,

Distribution pattern

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

device · product 6 of 6

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

Z-3079-2024
Recall number
Z-3079-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) Model No. STCB01, UPC N/A, LOT NUMBERS: 4201063, 4209005, 4307016, 4308061, 4311036; 2) Model No. STCB02, UPC N/A, LOT NUMBERS: 4201064; 3) Model No. 110101150020, UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01, UPC: Sole in Canada only, LOT NUMBERS: 4301023, 4308072, 4308073, 4309043, 4310029, 04311037, 4312011, 4312093, 4402006

Distribution pattern

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