Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; ... — FDA record Z-1390-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKM...
Reason
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
39315 units
Agency-reported status
Ongoing
Source record identifier
Z-1390-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 46) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 47) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 48) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 49) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 50) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 51) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 52) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 53) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 54) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 55) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 56) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24LBK995; 57) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24JBJ413; 58) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24IBM204; 59) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24GBQ632; 60) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24FBS248; 61) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBU862; 62) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBK620; 63) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBF421; 64) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24ABB897; 65) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23LBK827; 66) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23JBM632; 67) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23GBJ781; 68) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBQ953; 69) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBF165; 70) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23DBE827; 71) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23ABG192; 72) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22OBA486; 73) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22KBO918; 74) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22IBE745; 75) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBX514; 76) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBL409; 77) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 78) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 79) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 80) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 81) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 82) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 83) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 84) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBQ865; 85) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBN891; 86) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23BBG436; 87) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABG179; 88) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABF773; 89) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG079; 90) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG077; 91) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG072; 92) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF451; 93) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF439; 94) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22DBL431; 95) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE659; 96) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE658; 97) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21KBQ156; 98) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21IBO083; 99) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21HBO916; 100) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21CBG242; 101) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 102) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 103) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 104) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 105) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 106) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 107) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 108) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 109) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 110) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 111) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21GBS209; 112) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21BBH224; 113) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25DBQ683; 114) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25CBI244; 115) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBM940; 116) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBF438; 117) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24JBS428; 118) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24HBL828; 119) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24GBU141; 120) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24EBC679; 121) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24CBB817; 122) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24ABX492; 123) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBU791; 124) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBA214; 125) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23CBR891; 126) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22KBW189; 127) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22IBV957; 128) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22HBA238; 129) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22GLA269; 130) CDS980839C, UDI-DI: 10193489723076(each), 40193489723077(case), Lot Number: 21FBB093; 131) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25CMJ833; 132) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25BMD423; 133) CDS982564C, UDI-DI: 10193489873177(each), 401934898731...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Feb 25, 2026
Recall initiation date
Jan 7, 2026
Center classification date
Feb 17, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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