CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Medline Kits: Newborn Admission recalled by Medline Industries
Medline Industries is recalling Medline Kits: Newborn Admission, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 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-1842-2026
- FDA event ID
- 98599
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2026
- FDA classified
- 17 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 25 Feb 2026 | Recall initiated by company | |
| 17 Apr 2026 | Classified by FDA | +51 days |
| 29 Apr 2026 | 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
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which lots are 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
Where was it sold?
US Nationwide distribution.
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
21 other products · FDA event 98599This product is part of a recall event; the main page for the event is Medline Kits: Heart Transplant Biopsy recalled by Medline Industries.
More recalls from Medline Industries
All 709| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |