Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) 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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.