Medline Kits: 1) NEWBORN ADMISSION recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5. Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
What is being recalled
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V
Why
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
1) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869; 2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256; 3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998; 4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723; 5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579; 6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213; 7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220; 8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178; 9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194; 10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063; 11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583; 12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678; 13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724; 14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342; 15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978; 16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884; 17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22LBH141; 18) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE023; 19) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE024; 20) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE025; 21) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23CBP389; 22) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBB429; 23) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBQ437; 24) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23GBB278; 25) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23HBD985; 26) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23JBN242; 27) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP034; 28) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP432; 29) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABA416; 30) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24EBF244; 31) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBB647; 32) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBO960; 33) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBE249; 34) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBW947; 35) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24HBN439; 36) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24JBC123; 37) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24KBI920; 38) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24LBO860; 39) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBV362; 40) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23BBU890; 41) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABN982; 42) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 25HBM032; 43) DYNJT3719, UDI-DI: 10198459347054(each), 40198459347055(case), Lot Number: 25EBU996; 44) DYNJT5667, UDI-DI: 10198459492129(each), 40198459492120(case), Lot Number: 25HDB174; 45) DYNJWASTEKIT2, UDI-DI: 10193489548204(each), 40193489548205(case), Lot Number: 22HBK640; 46) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25DMI117; 47) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25BMC155; 48) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24FDB534; 49) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24HDC006; 50) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24IDB770; 51) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24KDA884; 52) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24LDA938; 53) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25ADB529; 54) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25BDB719; 55) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25DDB454; 56) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25HDA895; 57) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24DBD251; 58) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24EBF801; 59) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24FBD925; 60) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBY008; 61) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24HBN127; 62) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24JBT025; 63) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24KBF095; 64) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24LBK225; 65) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25BBA827; 66) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25CBF946; 67) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25DBH070; 68) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25EBK903; 69) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBC776; 70) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25GBS410; 71) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25BBB333; 72) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25CBI608; 73) DYNJ40886B, UDI-DI: 10193489768282(each), 40193489768283(case), Lot Number: 25ELA632; 74) DYNJ41553F, UDI-DI: 10198459079634(each), 40198459079635(case), Lot Number: 25EMI492; 75) DYNJ41558D, UDI-DI: 10889942811663(each), 40889942811664(case), Lot Number: 25EMC747; 76) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24HBE996; 77) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24IBD804; 78) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24JBH568; 79) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 25EBR969; 80) DYNJ48683A, UDI-DI: 10889942491377(each), 40889942491378(case), Lot Number: 24LBO769; 81) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25FMA909; 82) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25EMJ828; 83) DYNJ57785C, UDI-DI: 10195327543624(each), 40195327543625(case), Lot Number: 24BBN969; 84) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24CBB176; 85) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24DBR422; 86) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24FBO638; 87) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24HBT927; 88) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24IBP969; 89) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24JBH473; 90) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24KBG036; 91) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25CBH396; 92) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25EBE869; 93) DYNJ62683D, UDI-DI: 10195327556518(each), 40195327556519(case), Lot Number: 24ABP681; 94) DYNJ63668B, UDI-DI: 10195327550851(each), 40195327550852(case), Lot Number: 24HME110; 95) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23BMD400; 96) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23AMA569; 97) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24HBS684; 98) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBP876; 99) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBS147; 100) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24LBL583; 101) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25CBP938; 102) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25DBQ919; 103) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25FBD407; 104) DYNJ84040B, UDI-DI: 10198459254161(each), 40198459254162(case), Lot Number: 25BMG397; 105) DYNJ86600, UDI-DI: 10198459021565(each), 40198459021566(case), Lot Number: 25BBT025; 106) DYNJ89064, UDI-DI: 10198459230820(each), 40198459230821(case), Lot Number: 25ABL031; 107) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25ABS218; 108) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25BBC477; 109) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25CBC491; 110) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25DBC830; 111) DYNJ89959, UDI-DI: 10198459300912(each), 40198459300913(case), Lot Number: 25DBD397; 112) DYNJ903566D, UDI-DI: 10195327560829(each), 40195327560820(case), Lot Number: 25HBU069; 113) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21FBN722; 114) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21HBI274; 115) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21IBL093; 116) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21KBE009; 117) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21LBG338; 118) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22GBZ027; 119) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22JMB507; 120) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22KMC060; 121) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23BMF719; 122) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23CME266; 123) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMI182; 124) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23GMI509; 125) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23JME302; 126) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23KMI130; 127) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23LMH540; 128) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24BMA155; 129) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24GME966; 130) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24IMC690; 131) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24KMG557; 132) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21GBO411; 133) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMC753; 134) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 25GMD612; 135) DYNJ907013, UDI-DI: 10193489318630(each), 40193489318631(case), Lot Number: 25FLA929; 136) NAM0032, UDI-DI: 10195327694357(each), 40195327694358(case), Lot Number: 24LBG464; 137) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21DBF029; 138) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21GBV041; 139) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21IBQ150; 140) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21KBK856; 141) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21LBA326; 142) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22CBX005; 143) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22EBO968; 144) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22HBF991; 145) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22IBR901; 146) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABL896; 147) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABN264; 148) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBA069; 149) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBM493; 150) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23EBH545; 151) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23FBF982; 152) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23HBE007; 153) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23IBE867; 154) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23JBW353; 155) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24ABL399; 156) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBB750; 157) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBP944; 158) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24EBQ247; 159) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24FBB644; 160) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24HBV207; 161) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24KBI912; 162) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25CBQ305; 163) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25DBK904; 164) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22JBD604; 165) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23KBG280; 166) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25EBH405; 167) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 25EBV199; 168) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 24FBD352; 169) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBM012; 170) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBD891; 171) VASC1155, UDI-DI: 10888277760493(each), 40888277760494(case), Lot Number: 25GBN921; 172) VASC1404, UDI-DI: 10195327366568(each), 40195327366569(case), Lot Number: 23EBI565; 173) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25GBS655; 174) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25DBJ392; 175) VASC1415A, UDI-DI: 10195327678272(each), 40195327678273(case), Lot Number: 24LBH191; 176) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24GBM956; 177) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24HBN734; 178) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24JBS224; 179) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24LBL061; 180) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25BBQ097; 181) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBK254; 182) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBN756; 183) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBU919; 184) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25DBG067; 185) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24FBQ508; 186) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25EBQ528; 187) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25ABG557; 188) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25BBE970; 189) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25CBN926; 190) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBD516; 191) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBP919
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1842-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 25, 2026 |
| Reported | April 29, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 38014 units |
More recalls from Medline Industries, LP · all medical device recalls · recalls from February 2026