BRANMOOR
THURSDAY · 14 MAY 2026

FDA Device Recall Z-0765-2025

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193; 5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422; 6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045; 7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715; 8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481; 9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583; 10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920; 11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602; 12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614; 13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601; 14) MTS,NEURO,KIT, Item Number: 600602914; 15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111; 16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423; 17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552; 18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035; 19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723; 20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214; 21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921; 22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210; 23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110;

Lot / serial / GTIN: 1) 60130527 UDI-D:10193489046465(each), 20193489046462(case), Lot Number:0000133032; 2) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000129541; 3) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000134701; 4) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000129544; 5) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000128715; 6) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000133060; 7) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000131657; 8) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135723; 9) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135294; 10) 65071193 UDI-D:10193489060904(each), 20193489060901(case), Lot Number:0000130171; 11) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000135606; 12) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000134729; 13) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000137115; 14) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000130833; 15) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000131669; 16) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000129513; 17) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000128721; 18) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000129523; 19) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000132393; 20) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000134940; 21) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000144158; 22) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000139082; 23) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000130138; 24) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000132350; 25) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000135736; 26) 60232481 UDI-D:10193489053326(each), 30193489053320(case), Lot Number:0000129534; 27) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000133660; 28) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000136501; 29) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000131600; 30) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000131376; 31) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000130940; 32) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000132222; 33) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000141215; 34) 602301614 UDI-D:10193489072754(each), 30193489072758(case), Lot Number:0000133659; 35) 6010771601 UDI-D:10193489099843(each), 30193489099847(case), Lot Number:0000127859; 36) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000135717; 37) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000128447; 38) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000133121; 39) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000130573; 40) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000128607; 41) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000137751; 42) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000131878; 43) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000130577; 44) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000138084; 45) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000130187; 46) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000131883; 47) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000143095; 48) 60182723 UDI-D:10193489049817(each), 30193489049811(case), Lot Number:0000130988; 49) 602500214 UDI-D:10193489072815(each), 30193489072819(case), Lot Number:0000127874; 50) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000131619; 51) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000133025; 52) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000136559; 53) 601305210 UDI-D:10193489070989(each), 30193489070983(case), Lot Number:0000130984; 54) 601400110 UDI-D:10193489071337(each), 30193489071331(case), Lot Number:0000128757;

Quantity: 3930 units

Reason for recall

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

Recall record

Recall number
Z-0765-2025
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
US Nationwide Distribution
Recall initiated
2024-12-16
Classified by FDA Center
2025-01-15
FDA published
2025-01-22
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Firm location
Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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