Drug & Device Safety Atlas
Class II FDA device recall · Z-1390-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information 
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), 40193489873178(case), Lot Number: 24JMF683; 134) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24HMA337; 135) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24EMG641; 136) CDS982566K, UDI-DI: 10193489435597(each), 40193489435598(case), Lot Number: 21CBQ731; 137) CDS982575K, UDI-DI: 10193489734799(each), 40193489734790(case), Lot Number: 21BKA040; 138) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBS146; 139) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBQ075; 140) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBQ086; 141) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBF470; 142) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21GBK054; 143) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21EKA064; 144) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21DKA457; 145) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22LBS833; 146) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22JBP075; 147) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22IBU776; 148) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22GBM066; 149) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22FBF335; 150) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22EBL281; 151) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22DBI104; 152) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22BBQ149; 153) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 24BBB783; 154) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23LBS018; 155) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23KBK940; 156) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23IBP737; 157) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBT093; 158) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBF574; 159) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBU058; 160) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBL415; 161) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBT572; 162) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBL429; 163) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21FBF717; 164) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21EBC025; 165) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21DBP216; 166) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21CBK379; 167) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBR206; 168) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23FBU833; 169) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DMH143; 170) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DME288; 171) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25CME797; 172) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25HMA016; 173) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GMG706; 174) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GME704; 175) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMH340; 176) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMF022; 177) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25IMH581; 178) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 23BBE439; 179) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22KBI289; 180) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22IBD426; 181) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22HBI664; 182) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 21FBF442; 183) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24CME689; 184) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24AMD733; 185) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23KMC560; 186) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23HMC461; 187) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMH171; 188) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMG766; 189) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23FMI141; 190) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23EMF372; 191) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23DMH027; 192) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22KMH072; 193) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22JMB563; 194) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMF199; 195) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMB738; 196) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22FMC683; 197) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22CMB854; 198) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21LMA822; 199) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21KMA019; 200) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21JMB643; 201) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21IMH924; 202) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21GMC871; 203) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21FMD794; 204) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21AKA832; 205) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMF693; 206) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMC120; 207) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMG956; 208) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMB935; 209) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25KMI896; 210) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25JME849; 211) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25BMD134; 212) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 24LMC522; 213) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23BBJ754; 214) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23ABA881; 215) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22OBL943; 216) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22JBU821; 217) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22EBM615; 218) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMH819; 219) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMC359; 220) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21IMC057; 221) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GME785; 222) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GBA694; 223) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21BKA482; 224) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24LMC474; 225) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24KMC946; 226) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21KLB205; 227) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21ILA628; 228) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21HLA680; 229) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLB087; 230) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA312; 231) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA057; 232) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21FLA954; 233) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21EKA147; 234) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21DKA676; 235) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21BKA389; 236) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBV540; 237) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBP065; 238) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23ABP719; 239) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22OBI364; 240) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22LBQ630; 241) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22JBT625; 242) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22IBT454; 243) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22HBL442; 244) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22FBX071; 245) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22EBL445; 246) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22ABF746; 247) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24EBT292; 248) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24DBU415; 249) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBO822; 250) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBL931; 251) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23LBB141; 252) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23KBA264; 253) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23JBB129; 254) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 255) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 256) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBA684; 257) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 258) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 259) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 260) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 261) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 262) CDS984355F, UDI-DI: 10888277770348(each), 40888277770349(case), Lot Number: 20LKB341; 263) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23LLA067; 264) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23JLA617; 265) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23ILB099; 266) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23HLA237; 267) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA762; 268) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA569; 269) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA693; 270) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA544; 271) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22JLB146; 272) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILB092; 273) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILA721; 274) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22FLA187; 275) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22BLA378; 276) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA543; 277) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA499; 278) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21GLA223; 279) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21FLA649; 280) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21EKA150; 281) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA538; 282) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA352; 283) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 284) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24BLA231; 285) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 286) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21FBE255; 287) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21BBS510; 288) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21ABE734; 289) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21LBP381; 290) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21JBZ656; 291) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21IBO615; 292) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21HBD158; 293) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23JBT159; 294) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23HBP383; 295) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23FBV374; 296) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23EBS635; 297) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23DBR889; 298) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23ABT277; 299) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22LBD272; 300) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBP078; 301) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBD236; 302) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBT102; 303) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBE901; 304) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22GBU933; 305) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22DBS062; 306) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22BBS888; 307) CDS985215C, UDI-DI: 10193489780109(each), 40193489780100(case), Lot Number: 21DBH711; 308) CVT159AA, UDI-DI: 10193489457513(each), 40193489457514(case), Lot Number: 22DBL279; 309) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24FBJ229; 310) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24DBF439; 311) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24BBT324; 312) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23JBP216; 313) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23IBI960; 314) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23GBI903; 315) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23EBO066; 316) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23DBT226; 317) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22LBD173; 318) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22KBA324; 319) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22IBA742; 320) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22GBL773; 321) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22EBS701; 322) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBI986; 323) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBF497; 324) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21KBI013; 325) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21IBQ531; 326) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21HBC943; 327) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21FBO379; 328) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW789; 329) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW788; 330) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBV599; 331) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBK912; 332) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21HBL002; 333) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBO480; 334) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBJ355; 335) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBO542; 336) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBF909; 337) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBN048; 338) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBC538; 339) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBA605; 340) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBS016; 341) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBO740; 342) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBM813; 343) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBF850; 344) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21BBN597; 345) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABO823; 346) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABI967; 347) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22HLA262; 348) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLB050; 349) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLA352; 350) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELB070; 351) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELA030; 352) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22DLA405; 353) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22CLA548; 354) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22BLB034; 355) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA723; 356) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA370; 357) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21KLA410; 358) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21HLB002; 359) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA991; 360) DYKMBNDL

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide.

Recall record

Recalling firm
Medline Industries, LP
Product type
Devices
Recall number
Z-1390-2026
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Northfield, IL
Recall initiated
2026-01-07

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1390-2026 · Source: openFDA enforcement.